Tendon Injury - Hand Clinical Trial
Official title:
Passive Mobilization With Place and Hold Versus Active Motion Therapy After Flexor Tendon Repair: 5-year Minimum Follow-up of A Randomized Controlled Trial
NCT number | NCT04385485 |
Other study ID # | 1001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 14, 2014 |
Est. completion date | January 16, 2023 |
Verified date | January 2024 |
Source | Sahlgrenska University Hospital, Sweden |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to investigate if active mobilisation after flexor tendon repair in fingers gives better range of motion, strength, risk of rupture and patient satisfaction compared with passive mobilisation with place and hold after flexor tenon repair.
Status | Completed |
Enrollment | 64 |
Est. completion date | January 16, 2023 |
Est. primary completion date | August 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - Primary, complete injury to FDP in digit II-V - Injury in zone I och II - Operation within 72 hours from injury - The patient must be able to fulfill the rehabilitation program. Exclusion Criteria: - Concomitant fracture - Concomitant soft tissue defect - Severe crush injury - Palmar plate injury demanding immobilisation - Concomitant joint injury - Concomitant extensor tendon injury - Bilateral injury - Previous loss of function in the finger before the injury - Uncertainty if the patient can fulfill the rehabilitation - The surgeon think it is unsuitable with active training after surgery Concomitant injury of the flexor digitorum superficialis (FDS) or a digital nerve is accepted. A distal injury in zone I is not included if it requires a reinsertion of the tendon to the bone. |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Hand Surgery, Sahlgrenska University Hospital | Göteborg | Västra Götaland |
Lead Sponsor | Collaborator |
---|---|
Sahlgrenska University Hospital, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Range of motion | Range of motion in the proximal and distal interphalangeal joints in the injured finger and corresponding finger in the other hand are measured after 4, 8 and 12 weeks and after 6 and 12 months and minimum 5 years after surgery. We are interested to learn if there is a difference in range of motion between the two study groups. | Up to minimum 5 years after surgery | |
Secondary | Jamar grip strength | Grip strength is measured with a Jamar hydraulic hand dynamometer at 6 and 12 months and minimum 5 years after surgery. We are interested to learn if there is a difference in range of motion between the two study groups. | Up to minimum 5 years after surgery | |
Secondary | Key Pinch strength | Key pinch strength is measured with a hydraulic pinch gauge dynamometer at 6 and 12 months and minimum 5 years after surgery. We are interested to learn if there is a difference in range of motion between the two study groups. | Up to minimum 5 years after surgery | |
Secondary | Tendon rerupture | We record any reruptures continuously during the study period. If there are 3 consecutive reruptures in the active group the study is terminated immediately. | Up to minimum 5 years after surgery | |
Secondary | Need of secondary operation | At 6 and 12 months and minimum 5 years the need for secondary surgery is evaluated | Up to minimum 5 years after surgery | |
Secondary | Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure questionaire | DASH is an outcome questionnaire with 30 questions about functions and symptoms in the upper extremity, answered by the patient. Scores range from 0 (no disability) to 100 (completely disabled). The patients are given the DASH questionaries to fill in before surgery as a baseline and again after 3, 6 and 12 months and minimum 5 years. | Up to minimum 5 years after surgery |
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