Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-28 @ 12:57 AM
Study NCT ID:
NCT04653051
Status:
COMPLETED
Last Update Posted:
2024-11-20
First Post:
2020-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'georgia.tsapara@zimmerbiomet.com', 'phone': '+41 79 94 54936', 'title': 'Georgia Tsapara', 'organization': 'Zimmer Biomet'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The limitations of this study are that it was retrospective, over the pandemic and required extensive hours of discussion and contacting of patients which took extended time.'}}, 'adverseEventsModule': {'timeFrame': 'Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study.', 'description': 'Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.', 'eventGroups': [{'id': 'EG000', 'title': '111 Subjects Received DVR Plating System With a Mean Follow-up of 3.8 Years', 'description': 'Single study patient cohort, including 111 participants (115 patients) who meet the inclusion/exclusion criteria and who received the DVR Plating System', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 111, 'otherNumAffected': 59, 'seriousNumAtRisk': 111, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Pain due to altered sensation', 'notes': "Patient experiences shooting pains in hand. Surgery wasn't offered as wasn't thought to improve outcome. Subject is seeing independent specialist and was discharged from clinic.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Plate removal', 'notes': 'Patient had wrist plate removed due to "rubbing against nerve-screw was pressing against skin". Patient pointed out a small lump on the radial border of wrist which is quite tender and possibilities this may be a screw.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shoulder/ arm pain', 'notes': 'Patient received epidural injection for trapped nerve/shoulder/arm pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in wrist', 'notes': '1. Ongoing pain in wrist - described as "mild"\n2. Regular ongoing pain in wrist since operation when performing tasks with affected wrist\n3. Significant pain when using wrist and unable to straighten ring and little finger also weakness in wrist', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loose screw', 'notes': 'Patient said a screw was "loose" according to the x-rays during clinic appointment - has not caused any issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stiffness and pain', 'notes': '1. Stiffness and pain causing difficulty moving the hand-removal of used K-wires\n2. Shoulder pain and stiffness\n3. Stiffness in wrist', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shooting spasm pains', 'notes': 'Experiences shooting spasm pains down arm and wrist - especially when using wrist a lot during working. Pain is not bad enough to stop subject from doing anything.\n\n2- Patient experiences very occasional sudden shooting pain - no clear cause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rotator cuff impingement', 'notes': 'Rotator cuff impingement with long head of biceps medialisation. Severe stiffness due to multiple injuries and prolonged reduced mobilization.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Collapsed joint line', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'notes': "1. Patient reported there was a gap between the bones in wrist. Pain when using wrist and a 'clunking'\n2. Pain is flaring up from time to time. Very active and pain mostly occurs recently during activities like climbing Nothing to note in X-Rays", 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild ache', 'notes': '1. Patient experiences \'clicking\' in wrist when moving with a "mild ache"\n2. Patient experiences occasional mild pain when it\'s cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intermittent pain and instability', 'notes': 'Patient experiences intermittent pain in wrist and mentioned experiencing ongoing instability and it has some deformity -There was pre-existing instability of the DRUJ therefore the complication is unrelated to the device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower Respiratory Tract Infection (LRTI)', 'notes': 'Patient developed a LRTI post op and was given a course of antibiotics - extended hospital stay', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthritis', 'notes': '1. Reduced wrist function and occasional pain due to ongoing arthritis\n2. Patient developed arthritis in wrist\n3. Arthritis in wrist -pain, mostly in cold weather. Post-OP onset\n4. Arthritis in fingers- regular ongoing pain in wrist', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low wrist function', 'notes': 'Patient attributed lower rated wrist function due to "stiff fingers"- unable to make a fist with left hand', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Additional fall', 'notes': '1. Fall-no fracture but ligaments in arm/shoulder injured- pain affects wrist function\n2. Fall, mobilizing with crutches-numbness in thumb and tip of little finger-reduced finger mobility\n3. Patient had a subsequent fall, thumb injured- ongoing pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Discomfort and pain', 'notes': '1- Patient experienced discomfort and pain following operation. Shooting pain into ring and little finger, reduced grip and trouble rotating wrist', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Polytrauma', 'notes': 'Polytrauma - long hospital stay', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aching and pain', 'notes': 'Subject experiences aching and some pain depending on the weather - affects subject intermittently', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Plate removal', 'notes': '1. Ongoing pain and eventually had metalwork removed\n2. Pain caused plate removal\n3. Ulna plate fixation failed in osteoporotic bone causing need for revision ulna fixation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Long recovery', 'notes': 'Recovery after surgery took longer than the time frame the surgeon gave. Patient struggled to move fingers and wrist significantly post-surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Complex Regional Pain Syndrome', 'notes': 'Patient experiences significant pain when lifting any heavy object and has ongoing weakness in affected hand/wrist', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in wrist', 'notes': "1. Patient's wrist was still quite painful, causing some difficulty sleeping at night and has minimal range of movement - wrist was slightly swollen, slightly hypersensitive thumb with some occasional pins and needles\n2. Pain and discomfort in wrist", 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reduced ROM', 'notes': '1. Slightly reduced ROM-wrist flexion and some resistance when making a tight fist\n2. Reduced ROM in wrist\n3. Slight reduced range of motion- hand not flat during yoga\n4. Stiffness, reduced ROM and some pain\n5. Reduced wrist ROM affecting activities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain when lifting heavy objects', 'notes': 'Patient struggles with pain when lifting heavy objects (more than 5kg) and with repeated movements like using a tin opener or using bathroom tissue. Patient avoids these activities.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Occasional pain and slightly reduced ROM', 'notes': "Patient since operation gets occasional pain and slight reduced ROM, only at it's worse during cold weather. The pain rarely affects the patient.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Numbness', 'notes': 'Patient experiences numbness in thumb, index \\& middle fingers which is related to the nerve dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swollen wrist', 'notes': 'Swollen wrist with a globally reduced range of motion which results to the hand movement stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Polymyalgia', 'notes': 'Pain post operatively leading to prolonged stay. Background of Polymyalgia which can often predispose to pain control issues. Difficult to say if pain from swelling of original fracture of from procedure.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shooting nerve pain in wrist', 'notes': 'Patient experiences shooting/nerve pain in wrist when completing certain tasks like using a bathroom tissue. Does not occur often but can be really painful', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stitches opened', 'notes': "Patient's stitches/wound opened up the day after surgery - bleeding inside the cast. Went t back to hospital to have her wound re-dressed and re-cast.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bones moving forward', 'notes': 'Plate has not stopped the bones from moving forward', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tingling sensation', 'notes': '1. Patient experiences tingling sensation when touching the skin over the plate\n2. Patient experiences regular nerve pain/twinges, and pins \\& needles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clicking and minor weakness', 'notes': 'Patient experiences clicking in wrist when moving and some minor weakness when lifting heavy objects', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thicker wrist', 'notes': "Patient's operated wrist is thicker than other (non-operated) wrist", 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Plate pincing nerve', 'notes': 'Patient is complaining of the plate pinching a nerve in wrist causing issues with thumb (stiffness and poor flexibility)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss of power and grip strenght', 'notes': "1. Small amount of loss of power \\& grip strength\n2. Reduced grip strength-doesn't impact activities\n3. Reported lower grip strength in affected hand/wrist\n4. Reduced strength and infrequent pain-worse/intense when using wrist for certain activities", 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Concurring spinal injuries', 'notes': 'Patient had delayed discharge due to concurring spinal injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Collapse at fracture site', 'notes': 'Collapse at fracture site resulting in metalwork removal (plate and screws)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'notes': 'Back pain/nerve pain in back that sometimes affects both arms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stiffness and irritation caused by the plate', 'notes': '1. Patient experienced stiffness of wrist (no pain) and irritation cause by the plate\n2. Patient experiences significant stiffness and reduced range of motion resulting in the plate being removed. Stiffness remains after device removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dull ache', 'notes': 'Patient experiences dull ache in wrist, this pain can prevents patient from doing push-ups and from writing for extended periods of time', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wrist weakness', 'notes': 'Patient experiences some wrist weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Enlarged scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pins and needles feeling', 'notes': '1. Patient experiences ongoing pins and needles in affected hand/wrist\n2. Patient experiencing pins \\& needles in wrist, extending to forearm for the last 1-2 years', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain combined with stiffness', 'notes': '1. Patient has ongoing pain/aches in wrist, stiffness and reduced grip strength making majority of activities more difficult\n2. Patient gets pain when performing repeated wrist movements, has increased stiffness \\& reduced ROM when twisting wrist', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain when performing repeated wrist movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reduced strength', 'notes': "1. Patient has reduced level of strength in left hand\n2. Patient's wrist fatigues quickly and loses strength during use. The patient also experiences regular ongoing pain in wrist", 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inpatient fall', 'notes': 'Inpatient fall sustaining skull fracture with concurrent subdural hematoma - longer admission', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Altered sensation of the median nerve', 'notes': 'Altered sensation of the median nerve', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Car accident', 'notes': 'Fracture of ribs and hip due to a car accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reduced mobility', 'notes': 'Reduced mobility, as patient unable to use the left thumb which heavily impacts the ability to perform any task with left hand - patient reported this was due to a ruptured tendon as a result of plaster cast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "Kienbock's disease", 'notes': "Patient is experiencing ongoing significant pain due to Kienbock's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fracture Healing Based on Clinical Measures and X-rays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}, {'units': 'cases', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DVR Plating System', 'description': 'Single study patient cohort, including 111 participants (115 cases) who meet the inclusion/exclusion criteria and who received the DVR Plating System and have a mean follow-up of 3.8 years'}], 'classes': [{'title': 'X-ray Evaluation', 'categories': [{'title': 'Fracture/Osteotomy healed', 'measurements': [{'value': '103', 'groupId': 'OG000'}]}, {'title': 'Fracture/Osteotomy not healed', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Fracture/Osteotomy healing not assessed', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Clinical Evaluation', 'categories': [{'title': 'Fracture/Osteotomy healed', 'measurements': [{'value': '114', 'groupId': 'OG000'}]}, {'title': 'Fracture/Osteotomy not healed', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Fracture/Osteotomy healing not assessed', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Mean time of 3.8 years after the surgery', 'description': 'Fracture healing will be evaluated by x-rays and clinical measures (no pain at fracture site)', 'unitOfMeasure': 'cases', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'cases', 'denomUnitsSelected': 'cases'}, {'type': 'SECONDARY', 'title': 'Product Safety Based on Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}, {'units': 'complications classified per ISO14155', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DVR Plating System', 'description': 'Single study patient cohort, including 111 participants (115 cases) who meet the inclusion/exclusion criteria and who received the DVR Plating System and have a mean follow-up of 3.8 years'}], 'classes': [{'title': 'Adverse Events (AEs)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Events (SAEs)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Adverse Device Effects (ADEs)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Device Effects (SADEs)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Mean time of 3.8 years after surgery', 'description': 'Safety will be assessed by recording and analyzing the incidence and frequency of complications. The complications are classified per ISO 14155 Definitions: Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs).\n\n.', 'unitOfMeasure': 'complications classified per ISO14155', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'complications classified per ISO14155', 'denomUnitsSelected': 'complications classified per ISO14155', 'populationDescription': 'complications \\[Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs)\\] that occurred in the study cohort during the time of the study'}, {'type': 'SECONDARY', 'title': "Patient's Outcomes Were Also Assessed", 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}, {'units': 'cases', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DVR Plating System', 'description': 'Single study patient cohort, including 111 participants (115 cases) who meet the inclusion/exclusion criteria and who received the DVR Plating System and have a mean follow-up of 3.8 years'}], 'classes': [{'title': 'PRWE Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}, {'units': 'cases', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.8', 'spread': '17.9', 'groupId': 'OG000'}]}]}, {'title': 'General Wrist Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}, {'units': 'cases', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '2.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Mean time of 3.8 years after surgery', 'description': 'Patients were asked to complete a patient questionnaire (Patient-Rated Wrist Evaluation Score- PRWE)\\* and a question on their wrist function\\*\\*\n\n\\* the PRWE is a self-administered, patient-specific questionnaire that consists of 15 items. It was designed to measure wrist pain and disability in activities of daily living, and consists of two subscales: pain and function. A score of 100 represents the worst functional score, whereas 0 represents no disability\n\n\\*\\* Patient reported outcome: assessment of fractured wrist comparing to before injury on a scale from 0 to 10, 0 being worst imaginable, and 10 being as good as before the injury.', 'unitOfMeasure': 'cases', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'cases', 'denomUnitsSelected': 'cases', 'populationDescription': "In a case the General Wrist Function could not be assessed as the patient is suffering from Kienbock's disease and is experiencing a lot of pain, therefore the General Wrist Function is calculated for 113 cases."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DVR Plating System', 'description': 'Single study patient cohort, including 111 participants (115 cases) who meet the inclusion/exclusion criteria and who received the DVR Plating System and have a mean follow-up of 3.8 years'}], 'periods': [{'title': 'Last Consultation Visit at the Hospital', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '115', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '115', 'numSubjects': '111'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Follow-up Phone Call', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '114', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'One patient received two plates and one plate needed to be explanted before the follow.up phone call. Therefore this case, is not considered here', 'groupId': 'FG000', 'numUnits': '114', 'numSubjects': '111'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'cases', 'recruitmentDetails': 'Southampton General Hospital', 'preAssignmentDetails': '191 consecutive patients were identified at the Southampton General Hospital. 11 patients died or moved out of the area so they could not be enrolled. So 180 patients were contacted and were asked to consider their study participation. 69 patients were either not reachable within three attempts or declined study participation leaving us with 111 patients enrolled into this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}, {'units': 'cases', 'counts': [{'value': '115', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Subjects Received DVR Plating System', 'description': 'Single study patient cohort, including 111 participants (115 cases) who meet the inclusion/exclusion criteria and who received the DVR Plating System and have a mean follow-up of 3.8 years'}], 'measures': [{'title': 'Age, Continuous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}, {'units': 'cases', 'counts': [{'value': '115', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'measurements': [{'value': '60.1', 'spread': '18.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age in years', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'cases'}, {'title': 'Sex: Female, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}, {'units': 'cases', 'counts': [{'value': '115', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'cases', 'denomUnitsSelected': 'cases'}, {'title': 'Race and Ethnicity Not Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}, {'units': 'cases', 'counts': [{'value': '115', 'groupId': 'BG000'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}, {'units': 'cases', 'counts': [{'value': '115', 'groupId': 'BG000'}]}], 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'cases', 'denomUnitsSelected': 'cases'}, {'title': 'Weight, Continuous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}]}, {'units': 'cases', 'counts': [{'value': '64', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'measurements': [{'value': '73.8', 'spread': '17.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'cases', 'populationDescription': 'As the retrieval of the demographic data was not always possible the number of cases for the weight differs from the total amount of cases.'}, {'title': 'Height, Continuous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}]}, {'units': 'cases', 'counts': [{'value': '52', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'measurements': [{'value': '165.8', 'spread': '16.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'cases', 'populationDescription': 'As the retrieval of the demographic data was not always possible the number of cases for the height differs from the total amount of cases.'}, {'title': 'Body Mass Index, Continuous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}, {'units': 'cases', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'measurements': [{'value': '26.3', 'spread': '5.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'cases', 'populationDescription': 'As the retrieval of the demographic data was not always possible the number of cases for the body mass index differs from the total amount of cases.'}], 'typeUnitsAnalyzed': 'cases', 'populationDescription': "This is a retrospective study meaning that retrospective data from preoperative, operative, immediate postoperative and last consultation visit was collected from patients' charts that have been operated in the past. Due to this retrospective design of the study the retrieval of demographic information from past medical records was not always possible as some medical records did not contain all information."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-08', 'size': 254093, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-14T05:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-19', 'studyFirstSubmitDate': '2020-11-19', 'resultsFirstSubmitDate': '2022-12-20', 'studyFirstSubmitQcDate': '2020-11-26', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-19', 'studyFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fracture Healing Based on Clinical Measures and X-rays', 'timeFrame': 'Mean time of 3.8 years after the surgery', 'description': 'Fracture healing will be evaluated by x-rays and clinical measures (no pain at fracture site)'}], 'secondaryOutcomes': [{'measure': 'Product Safety Based on Complications', 'timeFrame': 'Mean time of 3.8 years after surgery', 'description': 'Safety will be assessed by recording and analyzing the incidence and frequency of complications. The complications are classified per ISO 14155 Definitions: Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs).\n\n.'}, {'measure': "Patient's Outcomes Were Also Assessed", 'timeFrame': 'Mean time of 3.8 years after surgery', 'description': 'Patients were asked to complete a patient questionnaire (Patient-Rated Wrist Evaluation Score- PRWE)\\* and a question on their wrist function\\*\\*\n\n\\* the PRWE is a self-administered, patient-specific questionnaire that consists of 15 items. It was designed to measure wrist pain and disability in activities of daily living, and consists of two subscales: pain and function. A score of 100 represents the worst functional score, whereas 0 represents no disability\n\n\\*\\* Patient reported outcome: assessment of fractured wrist comparing to before injury on a scale from 0 to 10, 0 being worst imaginable, and 10 being as good as before the injury.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medical Device', 'Performance', 'Safety', 'Clinical Benefits', 'Post-Market Clinical Follow-Up Study'], 'conditions': ['Distal Radius Fracture', 'Distal Ulna Fracture', 'Osteotomy']}, 'descriptionModule': {'briefSummary': "The study is a single-center, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the DVR Plates. The primary objective is the assessment of performance by analyzing fracture healing. The secondary objective is the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Patients' outcomes will also be assessed.", 'detailedDescription': 'The DVR plating system in this study includes the DVR Crosslock Distal Radial Plate, the DVR Volar Rim Plate and the DVR Wrist Plates.\n\nOne site will be involved in this study. The aim is to include a total of 112 consecutive series patients treated between 2014 and 2018. All potential study subjects will be required to participate in the Informed Consent Process.\n\nBaseline data from the preop, intraop, immediate post-op and last consultation visit will be available in medical notes and collected retrospectively. During a follow up phone call the patient will be asked to complete a patient questionnaire and a question on his/her wrist function. In addition, any complications since the last consultation visit at the clinic, information about and treatment of the complications will also be collected over the phone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients must have received one of the DVR Plates and who meet all of the inclusion and none of the exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All subjects must have been implanted with one of the DVR Plates according to the approved indications.\n\nExclusion Criteria:\n\n* Off-label use.\n* Cases where there is an active infection.\n* Conditions which tend to retard healing such as, blood supply limitations, previous infections, etc.\n* Insufficient quantity or quality of bone to permit stabilization of the fracture.\n* Conditions that restrict the patient's ability or willingness to follow postoperative instructions during the healing process.\n* Foreign body sensitivity - where material sensitivity is suspected, appropriate tests should be conducted and sensitivity ruled out prior to implantations.\n* Cases where the implant(s) would cross open epiphyseal plates in skeletally immature patients.\n* Cases with malignant primary or metastatic tumors which preclude adequate bone support or screw fixations, unless supplemental fixation or stabilization methods are utilized."}, 'identificationModule': {'nctId': 'NCT04653051', 'briefTitle': 'PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the DVR Plating System (Implant and Instrumentation) - A Retrospective Consecutive Series Study', 'orgStudyIdInfo': {'id': 'MDRG2017-89MS-14T'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who received DVR Plating System'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Hassan Achakri', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zimmer Biomet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}