Flexor TendonNCT01939808
Flexor Tendon Injury Rehabilitation Regime Study
A study testing Splint Neutral and Splint Extended in people with Flexor Tendon, run by St Helens & Knowsley Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Hand flexor tendons bend the fingers down towards the palm, and can be cut during a sharp penetrating injury (e.g. from a knife or saw). Damaged flexor tendons are repaired surgically with sutures (stitches). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Flexor Tendon
- What is being tested?
- Splint Neutral and Splint Extended
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Aug 2013to 24 Jun 2016
- 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
- Primary inclusion criteria for the study is patients who have had 100% division by sharp laceration to the Flexor Digitorum Profundus (FDP+)/Flexor Digitorum Superficialis (FDS) within zone I or II and who have undergone repair with cruciate and epitendinous suture. Patients with multiple digit involvement will be included in the study.
- All repairs performed with 3/0 prolene suture cruciate repair and 6/0 prolene for the epitendinous repair as per departmental protocol.
- Patients with digital nerve repair along with the above injury will be included in the study
Who cannot join
- Patients with associated phalangeal fractures, skin and soft tissue loss or who had vascular compromise will be excluded from the study.
- Patients with tendon repairs other than cruciate will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Splinting the Wrist in Extension Versus Neutral Positioning During Rehabilitation Following Zone I/II Flexor Tendon Repair
Hand flexor tendons bend the fingers down towards the palm, and can be cut during a sharp penetrating injury (e.g. from a knife or saw). Damaged flexor tendons are repaired surgically with sutures (stitches). After repair, a splint is applied to the fingers, hand and wrist for six to twelve weeks to protect the repair while the tendon heals and regains its normal strength.
Most rehabilitation protocols use a splint in which the wrist position is kept straight (neutral) or bent (flexed). Some groups have described splinting with the wrist cocked back (extended) and have made the argument that this may improve outcomes, as experimental data suggests that splinting the hand with the wrist extended increases the range of movement of the repaired flexor tendon (excursion), and therefore reduces the chance of the tendon sticking down to the surrounding tissues (adhesion). Previous studies have shown no adverse effects from splinting hands with the wrist extended, and no evidence tells us which wrist splint position is better (a state of clinical equipoise or apparently equivalent outcomes). This randomised trial aims to produce this evidence, and therefore improve functional outcomes for patients in future.
We propose to carry out a study to compare the outcomes (grip strength and range of movement) of flexor tendon repair in two groups of patients: one with wrists splinted in a neutral position and the other splinted in an extended position during their postoperative rehabilitation. No changes will be made to patient assessment and management,the surgery undertaken and the rehabilitation regime other than those to splint position. Previous work suggests that both positions are safe and effective. Informed consent will be obtained from all patients enrolled in the trial, and we aim to find out if the extended splint position produces better functional results.
- Conditions
- Flexor Tendon
- Being tested
- Splint Neutral, Splint Extended
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Splint NeutralOther
Splint ExtendedOther
| Study group | Role | What they receive |
|---|---|---|
| Wrist splinted in extended position | Other | We propose to carry out a study to compare the outcomes (grip strength and range of movement) of flexor tendon repair in two groups of patients: one with wrists splinted in a neutral position and the other splinted in an extended position during their postoperative rehabilitation Receives: Other: Splint Extended |
| Wrist Splinted in the Neutral postion | Other | We propose to carry out a study to compare the outcomes (grip strength and range of movement) of flexor tendon repair in two groups of patients: one with wrists splinted in a neutral position and the other splinted in an extended position during their postoperative rehabilitation Receives: Other: Splint Neutral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the Range of Movement up to 26 week post surgery
The primary outcome measures will be "Range of Movement" (ROM). Total active motion will be measured using a Roylan finger goniometer following a standardised procedure and recorded on an electronic audit form (Appendix 1.5). This will be recorded up to 26 weeks post surgeries. Outcome data will be taken and recorded by a senior hand therapist who will be blinded to the position of splintage that has been worn by the participant.
Measured: up to 26 weeks post surgery
Secondary outcomes (1)
Assessment of Grip Strength at 12 and 26 weeks post surgery
grip strength will be measured at both 12 and 26 weeks post surgery assessing change. This will be measured my using a Jamar Dynamometer and taken following a standard Procedure
Measured: 12 & 26 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study start15 Aug 2013
- Primary completion24 Jun 2016
- Study completion24 Jun 2016
Why it stopped: study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexor TendonStudies 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Helens & Knowsley Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939808
- Sponsor's protocol ID
- RBN854-STHK
- Status last verified
- Nov 2015
- First submitted
- 22 Aug 2013
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Splinting the Wrist in Extension Versus Neutral Positioning During Rehabilitation Following Zone I/II Flexor Tendon Repair
- ClinicalTrials.gov ID
- NCT01939808
- Acronym / sponsor ID
- RBN854-STHK
- Conditions
- Flexor Tendon
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St Helens & Knowsley Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 15 Aug 2013 (actual)
- Primary completion
- 24 Jun 2016 (actual)
- Study completion
- 24 Jun 2016 (actual)
- First posted
- 11 Sep 2013 (estimated)
- 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.
Hand flexor tendons bend the fingers down towards the palm, and can be cut during a sharp penetrating injury (e.g. from a knife or saw). Damaged flexor tendons are repaired surgically with sutures (stitches). After repair, a splint is applied to the fingers, hand and wrist for six to twelve weeks to protect the repair while the tendon heals and regains its normal strength.
Most rehabilitation protocols use a splint in which the wrist position is kept straight (neutral) or bent (flexed). Some groups have described splinting with the wrist cocked back (extended) and have made the argument that this may improve outcomes, as experimental data suggests that splinting the hand with the wrist extended increases the range of movement of the repaired flexor tendon (excursion), and therefore reduces the chance of the tendon sticking down to the surrounding tissues (adhesion). Previous studies have shown no adverse effects from splinting hands with the wrist extended, and no evidence tells us which wrist splint position is better (a state of clinical equipoise or apparently equivalent outcomes). This randomised trial aims to produce this evidence, and therefore improve functional outcomes for patients in future.
We propose to carry out a study to compare the outcomes (grip strength and range of movement) of flexor tendon repair in two groups of patients: one with wrists splinted in a neutral position and the other splinted in an extended position during their postoperative rehabilitation. No changes will be made to patient assessment and management,the surgery undertaken and the rehabilitation regime other than those to splint position. Previous work suggests that both positions are safe and effective. Informed consent will be obtained from all patients enrolled in the trial, and we aim to find out if the extended splint position produces better functional results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wrist splinted in extended position | Other | Other: Splint ExtendedWe propose to carry out a study to compare the outcomes (grip strength and range of movement) of flexor tendon repair in two groups of patients: one with wrists splinted in a neutral position and the other splinted in an extended position during their postoperative rehabilitation |
| Wrist Splinted in the Neutral postion | Other | Other: Splint NeutralWe propose to carry out a study to compare the outcomes (grip strength and range of movement) of flexor tendon repair in two groups of patients: one with wrists splinted in a neutral position and the other splinted in an extended position during their postoperative rehabilitation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Primary inclusion criteria for the study is patients who have had 100% division by sharp laceration to the Flexor Digitorum Profundus (FDP+)/Flexor Digitorum Superficialis (FDS) within zone I or II and who have undergone repair with cruciate and epitendinous suture. Patients with multiple digit involvement will be included in the study.
- All repairs performed with 3/0 prolene suture cruciate repair and 6/0 prolene for the epitendinous repair as per departmental protocol.
- Patients with digital nerve repair along with the above injury will be included in the study
Key exclusion criteria (2 listed)
- Patients with associated phalangeal fractures, skin and soft tissue loss or who had vascular compromise will be excluded from the study.
- Patients with tendon repairs other than cruciate will be excluded from the study
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 |
|---|---|---|
| Splint Neutral | Other | Wrist Splinted in the Neutral postion |
| Splint Extended | Other | Wrist splinted in extended position |
Primary outcome
Assessing the Range of Movement up to 26 week post surgery
Time frame: up to 26 weeks post surgery
The primary outcome measures will be "Range of Movement" (ROM). Total active motion will be measured using a Roylan finger goniometer following a standardised procedure and recorded on an electronic audit form (Appendix 1.5). This will be recorded up to 26 weeks post surgeries. Outcome data will be taken and recorded by a senior hand therapist who will be blinded to the position of splintage that has been worn by the participant.
1 secondary outcome
Assessment of Grip Strength at 12 and 26 weeks post surgery
Time frame: 12 & 26 weeks post surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
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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 Splint Neutral and Splint Extended in people with Flexor Tendon, run by St Helens & Knowsley Teaching Hospitals NHS 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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 19 Apr 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Assessing the Range of Movement up to 26 week post surgery (time frame: up to 26 weeks post surgery). 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 19 Apr 2019.