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

Primary Purpose

Tendon Injuries

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Short Splint
Traditional Long Splint
Sponsored by
Manchester University NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendon Injuries

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Manchester University NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Short Splint

Traditional, Long Splint

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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

Full Information

First Posted
February 13, 2019
Last Updated
August 10, 2020
Sponsor
Manchester University NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03850210
Brief Title
The Manchester Short Splint in the Rehabilitation of Zone II Flexor Tendon Repairs
Acronym
Short Splint
Official Title
The Manchester Short Splint in the Rehabilitation of Zone II Flexor Tendon Repairs
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manchester University NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendon Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short Splint
Arm Type
Experimental
Arm Title
Traditional, Long Splint
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Short Splint
Intervention Description
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
Intervention Name(s)
Traditional Long Splint
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in range of motion of the proximal interphalangeal joint of the injured digit at baseline and 6 months
Description
Range of motion of the proximal interphalangeal joint of the injured digit as measured by hand therapist using goniometer (angle measuring device)
Time Frame
Active and passive motion ranges to be recorded at 3 and 6 months
Secondary Outcome Measure Information:
Title
Rupture of repaired flexor tendon
Description
• 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
Time Frame
Monitored at 3 and 6 months
Title
Tendon adhesions needing tenolysis
Description
• Tendon adhesions diagnosed by differential active/passive range of motion as measured by hand therapist using goniometer. Confirmed by responsible surgeon
Time Frame
Monitored at 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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