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

Tendon Injuries Clinical Trial

— Short Splint  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03850210
• Other study ID #: 2015BP001
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tendon Injuries

Intervention

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.
• 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

Locations

Country	Name	City	State
United Kingdom	Manchester University NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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