Tendon InjuriesShort SplintNCT03850210
The Manchester Short Splint in the Rehabilitation of Zone II Flexor Tendon Repairs
A study testing Short Splint and Traditional Long Splint in people with Tendon Injuries, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Tendon Injuries
- What is being tested?
- Short Splint and Traditional Long Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2015to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult male and female patients 16 years and over, undergoing surgical repair of zone II flexor tendon injury in a single digit
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, M23 9LT
About this study
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
- Being tested
- Short Splint, Traditional Long Splint
- Medical subject headings
- Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short SplintDevice
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 SplintDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Short Splint | Experimental | Not described Receives: Device: Short Splint |
| Traditional, Long Splint | Active comparator | Not described Receives: Device: Traditional Long Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Active and passive motion ranges to be recorded at 3 and 6 months
Secondary outcomes (2)
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
Measured: Monitored at 3 and 6 months
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
Measured: Monitored at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Jun 2015
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendon InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850210
- Sponsor's protocol ID
- 2015BP001
- Acronym
- Short Splint
- Status last verified
- Aug 2020
- First submitted
- 13 Feb 2019
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Manchester Short Splint in the Rehabilitation of Zone II Flexor Tendon Repairs
- ClinicalTrials.gov ID
- NCT03850210
- Acronym / sponsor ID
- Short Splint / 2015BP001
- Conditions
- Tendon Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short Splint | Experimental | Device: Short Splint |
| Traditional, Long Splint | Active comparator | Device: Traditional Long Splint |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult male and female patients 16 years and over, undergoing surgical repair of zone II flexor tendon injury in a single digit
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short SplintShort Splint that permits maximal wrist flexion and up to 45° of wrist extension with a block to 30° of MCP joint extension. | Device | Short Splint |
| Traditional Long SplintTraditional 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 | Device | Traditional, Long Splint |
Primary outcome
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)
2 secondary outcomes
Rupture of repaired flexor tendon
Time frame: Monitored at 3 and 6 months
Tendon adhesions needing tenolysis
Time frame: Monitored at 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Splint and Traditional Long Splint in people with Tendon Injuries, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.