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Completed

NCT Number: NCT03850210

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

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.

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Key information

Conditions

Tendon Injuries Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manchester University NHS Foundation Trust

Manchester, M23 9LT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Change in range of motion of the proximal interphalangeal joint of the injured digit at baseline and 6 months

    Time frame: Active and passive motion ranges to be recorded at 3 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 outcomes

  1. Rupture of repaired flexor tendon

    Time frame: Monitored at 3 and 6 months

    • 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

  2. Tendon adhesions needing tenolysis

    Time frame: Monitored at 3 and 6 months

    • Tendon adhesions diagnosed by differential active/passive range of motion as measured by hand therapist using goniometer. Confirmed by responsible surgeon

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Registry information

Acronym: Short Splint

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Feb 21, 2019
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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