Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-02-02 @ 12:01 PM
Study NCT ID:
NCT02536157
Status:
COMPLETED
Last Update Posted:
2019-03-21
First Post:
2015-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Volar Plate Injury: A Comparison of Two Splinting Methods
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-19', 'studyFirstSubmitDate': '2015-08-21', 'studyFirstSubmitQcDate': '2015-08-26', 'lastUpdatePostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range of movement measured with a Jamar finger goniometer.', 'timeFrame': 'One week', 'description': 'Range of movement measured with a Jamar finger goniometer.'}, {'measure': 'Range of movement measured with a Jamar finger goniometer.', 'timeFrame': 'Four weeks', 'description': 'Range of movement measured with a Jamar finger goniometer.'}, {'measure': 'Range of movement measured with a Jamar finger goniometer.', 'timeFrame': 'Twelve weeks', 'description': 'Range of movement measured with a Jamar finger goniometer.'}], 'secondaryOutcomes': [{'measure': 'Pain measured using a 100mm visual analogue scale.', 'timeFrame': 'One, four and twelve weeks', 'description': 'Measured using a 100mm visual analogue scale.'}, {'measure': 'Function of the upper limb measured using the DASH questionnaire.', 'timeFrame': 'One, four and twelve weeks', 'description': 'Disabilities of the Shoulder, Arm and Hand Questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Volar plate', 'Splint', 'Proximal interphalangeal joint', 'Palmar plate', 'Hyperextension injury'], 'conditions': ['Volar Plate Injury of the Proximal Interphalangeal Joint']}, 'descriptionModule': {'briefSummary': "Which splinting method produces the best outcomes (in range of movement, pain and function) in the non-operative treatment of stable volar plate injuries in adults?\n\nThe volar plate is a ligament located at the middle knuckle (proximal interphalangeal joint - PIPJ) of the finger. It is commonly injured through hyperextension, for example a ball hitting the fingertip. Current treatment in the Hand Therapy Unit involves splinting the injured joint dorsally (on the back of the finger) into 20⁰ flexion (bent) using thermoplastic material. However, there is a potential risk of developing permanent stiffness of the PIPJ into straightening, once the volar plate ligament heals. To reduce this risk, the study aims to investigate if using a volar (on the front of the finger) gutter splint in 0⁰ flexion (straight), which still prevents hyperextension, achieves better outcomes. There is no existing high-quality evidence comparing these two methods.\n\nThis is a randomised controlled trial. For the purposes of this study, the current treatment of a 20° dorsal block splint will act as the control group. The intervention group will be the volar gutter splint group. A convenience sample will be used and all patients (over 16 years old) presenting to the Mid Yorkshire Hospitals NHS Trust's Hand Therapy Unit will be invited to participate in the study, with consideration to inclusion/exclusion criteria. Participants will be randomised into one of two groups through the use of a random number generator. The outcomes assessed will be range of movement, pain and function. These will be measured at initial assessment, four and twelve weeks. These are all average normal time intervals that patients are seen. Each splint is worn for four weeks and participants will receive standardised advice, exercises and treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All stable volar plate injuries.\n2. Aged 16 and older.\n3. Male and female.\n4. Acute presentation within 2 weeks of injury.\n5. All ethnic groups speaking English.\n\nExclusion Criteria:\n\n1. Vulnerable patient groups or those lacking capacity.\n2. Previous injury or pathology involving the same digit.\n3. Surgical intervention\n4. Unstable proximal interphalangeal joint.\n5. Concomitant tendon or additional bony injury outside the traditional Eaton classification types of volar plate injury.\n6. The DASH outcome measure is available and validated in 27 languages. However, those who do not speak/understand English well will unfortunately be excluded. This is an educational project and therefore there is no funding to use a translator service.\n7. Volar plate injuries are just as common in children and teenagers as adults. But under 16s will be excluded from this study as the DASH questionnaire has only been assumed valid in adults. There is no research investigating its use in younger age-groups.'}, 'identificationModule': {'nctId': 'NCT02536157', 'briefTitle': 'Volar Plate Injury: A Comparison of Two Splinting Methods', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Health Service, United Kingdom'}, 'officialTitle': 'A Randomised Controlled Trial Investigating the Effectiveness of Two Splinting Methods in the Non-operative Management of Volar Plate Injuries at the Proximal Interphalangeal Joint', 'orgStudyIdInfo': {'id': '12020625'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dorsal block splint', 'description': 'Thermoplastic splint in 20 degrees flexion applied to the dorsum of the PIPJ.', 'interventionNames': ['Device: Thermoplastic splinting']}, {'type': 'EXPERIMENTAL', 'label': 'Volar gutter splint', 'description': 'Thermoplastic splint in 0 degrees flexion applied to the volar surface of the finger.', 'interventionNames': ['Device: Thermoplastic splinting']}], 'interventions': [{'name': 'Thermoplastic splinting', 'type': 'DEVICE', 'armGroupLabels': ['Dorsal block splint', 'Volar gutter splint']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WF1 4DG', 'city': 'Wakefield', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': 'Hand Therapy Unit, Mid Yorkshire Hospitals NHS Trust, Pinderfields General Hospital, Aberford Road,', 'geoPoint': {'lat': 53.68331, 'lon': -1.49768}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Health Service, United Kingdom', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Bradford', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Physiotherapist', 'investigatorFullName': 'Claire Paxman', 'investigatorAffiliation': 'National Health Service, United Kingdom'}}}}