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

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.

Study Overview

• Status: Completed
• Conditions: Tendon Injuries
• Intervention / Treatment: Device: Short Splint; Device: Traditional Long Splint

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M23 9LT
    • Manchester University NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short Splint	Device: Short Splint; Short Splint that permits maximal wrist flexion and up to 45° of wrist extension with a block to 30° of MCP joint extension.
Active Comparator: Traditional, Long Splint	Device: Traditional Long Splint; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Tendon Injuries
• Other Study ID Numbers: 2015BP001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No