Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT06909760
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-17
First Post:
2025-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Myth Orthopaedic Implant Pain in Cold Weather
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-05-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2025-03-17', 'studyFirstSubmitQcDate': '2025-03-27', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain on the extremity which was operated', 'timeFrame': 'Patients are called for follow up twice a year with 6 months interval', 'description': 'Pain will be assessed with "Visual Analogue Scale". Patients will be asked if they have pain on their extremity with orthopedic implant both in cold and hot weather conditions.'}], 'secondaryOutcomes': [{'measure': 'range of motion of the affected joints', 'timeFrame': 'Patients are called for follow up twice a year with 6 months interval', 'description': 'Range of motion of the affected extremities will be evaluated with goniometer. Affected joints mean the joints which is proximal and distal to orthopedic implant used. If there is an implant in tibia. Range of motion of the knee and ankle joints will be measured.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain', 'implant', 'cold weather'], 'conditions': ['Pain', 'Cold Temperature']}, 'descriptionModule': {'briefSummary': 'In daily practice, the investigators frequently hear patients with orthopaedic implants complaining of implant pain and coldness in the implant area in cold weather in outpatient clinics. However, when the literature is examined, there is only one study examining the effect of cold weather on the implant and only the pain in cold weather was questioned in this study. In this study, the investigators aimed to obtain clearer information by comparing the effect of cold air on orthopaedic implants with hot air with many parameters.', 'detailedDescription': "Fractures and degenerative joint diseases are common medical problems that many people experience throughout their lives. Orthopaedic implants are widely manufactured and used worldwide to replace a degenerated joint or to reduce a fractured bone and promote healing (1). In a 1988 incidence study, it was estimated that 4.9 million people in the USA had fixation material (2). Today, this rate is thought to increase much more due to increasing population, developing and increasing number of motorised vehicles and increasing surgical indications. Although the removal of these implants is a very controversial issue in the literature, most surgeons do not recommend routine removal of implants unless there are complications (3). In a study, it was reported that the reasons for implant removal were osteomyelitis and persistent pain in only 28% of patients, but the reason for removal was 'patient request' in 72% of patients who had implants removed (4).\n\nIn daily practice, the investigators frequently hear patients with orthopaedic implants complaining of implant pain and coldness in the implant area in cold weather in outpatient clinics. However, when the literature was examined, there was only one study examining the effect of cold weather on the implant and only the pain in cold weather was questioned in this study. In this study, the investigators aimed to obtain clearer information by comparing the effect of cold air on orthopaedic implants with hot air with many parameters."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged ≥ 18 years with orthopaedic implants due to orthopaedic trauma.\n\nExclusion Criteria:\n\n* Patients \\<18 years of age\n* Patients with incomplete fracture union\n* Patients with joint prosthesis (knee, hip, shoulder prosthesis, etc.)\n* Patients with complications in the operated extremity (implant infection, implant failure, etc.)\n* Acute or chronic infection (bacterial or viral infection) of any body site\n* Patients diagnosed with neuropathy (diabetic, alcoholism, autoimmune, nutritional deficiency, infectious)'}, 'identificationModule': {'nctId': 'NCT06909760', 'briefTitle': 'A Myth Orthopaedic Implant Pain in Cold Weather', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ankara Etlik City Hospital'}, 'officialTitle': 'A Myth Orthopaedic Implant Pain in Cold Weather', 'orgStudyIdInfo': {'id': 'Implant Pain in Cold'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with orthopaedic implants', 'description': 'The contact information of the patients who volunteered to participate in the study will be obtained and the patients will be called for 2 separate controls based on the one-week average value of the air temperature (2 periods with a one-week average air temperature between 27-35°C (hot weather) and 0-8°C (cold weather)).\n\nParameters to be investigated in patients called for control in both weather conditions;\n\n* Whether there are any complaints at the implant site\n* Visual pain score (VAS)\n* Proximal and distal range of motion (ROM) of the operated extremity\n* Chills/shivering according to the opposite extremity\n* Pain catastrophizing scale (PCS)\n* Measures taken in cold weather\n* The temperature difference between the implant site and the same site in the opposite extremity will be measured using thermal thermometers.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06170', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ahmet Acar', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Etlik City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Supervisor İnvestigator', 'investigatorFullName': 'Ahmet Berkay Girgin', 'investigatorAffiliation': 'Ankara Etlik City Hospital'}}}}