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

NCT ID: NCT03850210

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2020-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Study Groups

Short Splint

Group Type: EXPERIMENTAL

Short Splint

Intervention Type: DEVICE

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

Traditional, Long Splint

Group Type: ACTIVE_COMPARATOR

Traditional Long Splint

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Manchester University NHS Foundation Trust

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

2015BP001

Identifier Type: -

Identifier Source: org_study_id