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

Not Applicable

Completed

• Conditions: Tendon Injuries
• Interventions: Device: Short Splint; Device: Traditional Long Splint

• Registration Number: NCT03850210
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-01
• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-21
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short Splint	Short Splint	-
Traditional, Long Splint	Traditional Long Splint	-

Primary Outcome Measures

Name	Time	Method
Change in range of motion of the proximal interphalangeal joint of the injured digit at baseline and 6 months	Active and passive motion ranges to be recorded at 3 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)

Secondary Outcome Measures

Name	Time	Method
Rupture of repaired flexor tendon	Monitored at 3 and 6 months	• 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
Tendon adhesions needing tenolysis	Monitored at 3 and 6 months	• Tendon adhesions diagnosed by differential active/passive range of motion as measured by hand therapist using goniometer. Confirmed by responsible surgeon

Trial Locations

Locations (1)

Manchester University NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom