Clinical Trial Comparing Active and Passive Rehabilitation After Flexor Tendon Injury

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
64 patients are goint to be included in the study. All of these are referred to the Hand surgery Clinic at Sahlgrenska University Hospital. Potential patients are informed about the study and those who accept sign an informed consent before randomisation. The surgery is performed in the same way for all patients. The rehabilitation is initiated the day after surgery or on the first working day if the surgery is done during a weekend. The randomisation was done by a computer program and the two different mobilisation protocols are placed accordingly in sealed envelopes numbered from 1 to 64. The envelopes are used one after another in a consecutive order. The patients are randomised after surgery but before initaition of rehabilitation. Inclusion criteria are: primary injury in flexor digitorum profundus (FDP) in dig II-V, repair within 3 days after injury, injury in zone I or II, age over 16 years, ability of the patient to go through early mobilisation and signed informed consent. Exclusion criteria are: concomitant severe injury in the hand such as fracture, injury in a joint, extensor tendon or volar plate, soft tissue defects or crushinjuries, bilateral flexor tendon injuries, previous impared function in the finger, uncertainty of compliance to the rehabilitation protocol or the surgeon find the active mobilisation unsuitable for any reason. Concomitant injury to the flexor digitorum superficialis (FDS) or a digital nerv is accepted and not an exclusion criteria. A distal injury in zone I is usually not included because of the need for reinsertion. All tendons are sutured in the same way with an end-to-end suture. All the operations are done by specialists in hand surgery or experienced residents in hand surgery at the clinic. The FDP tendon is repaired with a four-stranded core suture with a 4-0 Ti-cron (nonabsorbable braided polyesther) and a running epitendinous suture according to Silfverskiöld with a 6-0 Prolene (nonabsorbable monofil polypropylene). Any concomitant injury of the FDS tendon is repaired according to the surgeons preference. Any digital nerve is repaired with microsurgical instruments and a 8-0 or 9-0 S&T (non-absorbable polyamide monofilament). Rehabilitaion 1-3 days after surgery the patient will be randomised to either passive mobilisation with rubber bands and active place-and-hold or to pure active rehabilitation at the hand rehabilitation unit in our clinic. The patients in both groups are closely followed by an occupational therapist for 12 weeks. Additional follow-up appointments are planned after 6 and 12 months. Patients in both groups are allowed to do all kinds of normal activity after 3 months and heavy manual work and gym training after 4 months. Active mobilisation The active mobilisation program is based on the two programs, Belfast (ref) and Billericay (ref). Our program is a mix between these two. On the first day of mobilisation (1-3 days after surgery) the dressings are changed and a dorsal splint with the wrist in neutral position and the metacarpophalangeal (MCP) joints in 60-80 degrees of flexion is made for the patient. Another removable volar plate keeping the fingers extended is used in addition to the dorsal splint between training sessions. The patient is instructed to flex the fingers passively with the other hand and then keep the fingers in flexion and do an active hold for 3 seconds. Then the fingers are extended actively as far as the splint allowes. This motion is done with 5 repetitions, 10 times per day with 1.5 hour resting period between sessions. Every second training session (i.e. every third hour) all fingers are flexed actively three times. After a week both the passive motion with place-and-hold and the true active motion is done with 10 repetions, 10 times per day with a restingtime of 1.5 hours between training sessions. Four weeks post surgery flexion and extension of the wrist is added with 10 repetitions, 4 times per day and joint-by-joint training for the injured finger with 3 repetitions 10 times per day in addition to the previous protocol. Passive mobilisation with place-and-hold Before the mobilisation starts the patients get their dressings changed and a new dorsal forearm plaster ending at the level of the proximal interphalangeal (PIP) joints with the wrist in neutral position and a dorsal block over the proximal phalanges creating an extensionblock for the MCP-joints of 60-80 degrees. Rubberbands are attached to all the fingernails and a small hook is fastened to the plaster to hang the rubberbands on creating a resting position for the fingers between training sessions. A night splint with the interphalangeal joints in extension is also made to protect the fingers and keep them in full extension when the patient sleeps. The patient is instructed to flex the fingers passively with the other hand one at a time and then keep the fingers in flexion and do a gentle squeeze, so called place-and-hold. Then the fingers are extended actively as far as the plaster allows. For four weeks the patient do this exercise with 10 repetitions, 10 times a day (7-8 repetitions on the first day) with a resting period of 1.5 hours between sessions. After four weeks the plaster is removed and replaced by a splint protecting the wrist in neutral position and the patient adds true active flexion of the fingers to the previous program with 10 repetitions 10 times per day. Six weeks post surgery the splint is removed and flexion and extension of the wrist is initiated.

Official Title
-----------------
Primary Flexor Tendon Repair in Zone I and II, a Prospective Randomised Trial of Passive Mobilisation With Place-and-hold, Compared With True Active Motion Therapy

Conditions
-----------------
Tendon Injury - Hand

Intervention / Treatment
-----------------
* Procedure: Active rehabilitation
* Procedure: Passive rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The Patients are randomised 1-3 days after surgery to either active or passiv rehabilitation. The randomisation was done by a statistical software program (Medstat) and the protocols are placed in numbered sealed envelopes.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active rehabilitation<br>The patient see an occupational therapist 1-3 days after surgery. A splint is made to immobilise the wrist and work as a extension block for the MCP-joints. This splint has to be worn day and night for 4 weeks. Another splint that immobilise the DIP- and PIP-joints are worn whenever the patient is not exercising. During active exercise the patient follows a strict protocol with both active and passive training and increasing number of repetitions. The rehabilitation is proceeding for 3 months. | Procedure: Active rehabilitation<br>* We investigate if active rehabilitation is as good as passive rehabilitation after flexor tendon suture.<br>|
| Active Comparator: Passive rehabilitation<br>1-3 days after surgery the patient gets a new plaster that immobilise the wrist and work as an extension block for the MCP-joints. The occupational therapist attach rubberbands to the nails of all the fingers and the training is done passively with active hold according to a strict protocol. The training with rubberbands is done during 4 weeks. After that the rehabilitation is active. The rehabilitation is proceeding for 3 months. | Procedure: Passive rehabilitation<br>* We investigate if active rehabilitation is as good as passive rehabilitation after flexor tendon suture.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion | Range of motion in the proximal and distal interfalangeal joints in the injured finger and corresponding finger in the other hand are measuered after 4, 8 and 12 weeks and after 6 and 12 months. We are interested to learn if there is a difference in range of motion between the two study groups. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jamar grip strength | Grip strength is measured with a Jamar hydraulic hand dynamometer at 6 and 12 months after surgery. We are interested to learn if there is a difference in range of motion between the two study groups. | 12 months | 
| Key Pinch strength | Key pinch strength is measured with a hydraulic pinch gaugedynamometer at 6 and 12 months after surgery. We are interested to learn if there is a difference in range of motion between the two study groups. | 12 months | 
| Tendon rerupture | We record any reruptures continously during the study period. If there are 3 consecutive reruptures in the active group the study is terminated immediatly. | 12 months | 
| Need of secondary operation | At 6 and 12 months the need for secondary surgery is evaluated | 12 months | 
| DASH outcome measure questionaire | DASH is an outcome questionnaire with 30 questions about functions and symptomes 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. | 12 months |