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

NCT03850210 | Completed DMC

• 1 other identifier: 2015BP001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tendon Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rupture of repaired flexor tendon

  Monitored at 3 and 6 months

• Tendon adhesions needing tenolysis

  Monitored at 3 and 6 months

Study Arms (2)

Short Splint

EXPERIMENTAL

Device: Short Splint

Traditional, Long Splint

ACTIVE COMPARATOR

Device: Traditional Long Splint

Interventions

Short Splint DEVICE

Short Splint that permits maximal wrist flexion and up to 45° of wrist extension with a block to 30° of MCP joint extension.

Short Splint

Traditional Long Splint DEVICE

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

Traditional, Long Splint

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and female patients 16 years and over, undergoing surgical repair of zone II flexor tendon injury in a single digit

You may not qualify if:

• 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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M23 9LT, United Kingdom

Location

MeSH Terms

Conditions

Tendon Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 21, 2019
• Study Start: June 1, 2015
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)