The Manchester Short Splint in the Rehabilitation of Zone II Flexor Tendon Repairs

Study Overview
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Brief Summary
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The project sets out to compare two different splints in the outcome of zone II flexor tendon injury hand therapy rehabilitation programme. Traditional hand therapy is based on using a long forearm-based splint for 6 weeks in zone II flexor tendon injuries. Manchester University NHS Foundation Trust have devised a new shorter splint to use as an alternative to the traditional longer splint as there are cogent reasons for believing that permitting more wrist movement during rehabilitation will improve the range of finger movement ultimately (tendonesis effects). Patients will be randomised to receive either the traditional long splint, or the short splint. Patients will be followed up and data will be collected at routine hand therapy appointments.

Official Title
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The Manchester Short Splint in the Rehabilitation of Zone II Flexor Tendon Repairs

Conditions
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Tendon Injuries

Intervention / Treatment
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* Device: Short Splint
* Device: Traditional Long Splint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male and female patients 16 years and over, undergoing surgical repair of zone II flexor tendon injury in a single digit Exclusion Criteria: Adult patients lacking capacity or motivation to participate in the planned physiotherapy Adult patients with special needs and vulnerable groups Adult patients who undergo surgical repair of their flexor tendon more than 4 days after the initial injury Patients unable to understand English adequately Adult patients unable to attend the hospital facility for the requisite number of planned physiotherapy sessions (social reasons) Adult patients with multiple level injuries Injuries with soft tissue loss requiring coverage Adult patients with two nerve injuries on the same finger Adult patients with multiple digit flexor tendon injury Adult patients with concomitant bony injury to the hand Children under 16 years age

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short Splint<br> | Device: Short Splint<br>* Short Splint that permits maximal wrist flexion and up to 45° of wrist extension with a block to 30° of MCP joint extension.<br>|
| Active Comparator: Traditional, Long Splint<br> | Device: Traditional Long Splint<br>* Traditional splint is a forearm-based dorsal thermoplastic splint that immobilizes the wrist in neutral position with a block to 30° of metacarpophalangeal (MCP) joint extension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in range of motion of the proximal interphalangeal joint of the injured digit at baseline and 6 months | Range of motion of the proximal interphalangeal joint of the injured digit as measured by hand therapist using goniometer (angle measuring device) | Active and passive motion ranges to be recorded at 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rupture of repaired flexor tendon | • Rupture of repaired flexor tendon which is assessed and determined clinically by the treating hand therapist and confirmed by the responsible surgeon. Determined ruptured when there is no 'pull through' and the finger does not flex on attempted active movement | Monitored at 3 and 6 months | 
| Tendon adhesions needing tenolysis | • Tendon adhesions diagnosed by differential active/passive range of motion as measured by hand therapist using goniometer. Confirmed by responsible surgeon | Monitored at 3 and 6 months |