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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03850210
Acronym
Short Splint
Enrollment
60
Registered
2019-02-21
Start date
2015-06-01
Completion date
2020-06-30
Last updated
2020-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tendon Injuries

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.

Interventions

DEVICEShort Splint

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

DEVICETraditional 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

Sponsors

Manchester University NHS Foundation Trust
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in range of motion of the proximal interphalangeal joint of the injured digit at baseline and 6 monthsActive and passive motion ranges to be recorded at 3 and 6 monthsRange of motion of the proximal interphalangeal joint of the injured digit as measured by hand therapist using goniometer (angle measuring device)

Secondary

MeasureTime frameDescription
Rupture of repaired flexor tendonMonitored 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
Tendon adhesions needing tenolysisMonitored 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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026