Flexor Tendon RuptureNCT05809102
Repair Of Flexor Tendon In Zone II Using Minimal Incisions
A study testing repair of flexor tendon in Zone II in people with Flexor Tendon Rupture, run by Assiut University at 1 site in Egypt.
Trial summary
Repair of the zone II flexor tendon of the hand using minimal incisions is successful with good results which will improve the outcome of the repair. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Flexor Tendon Rupture
- What is being tested?
- repair of flexor tendon in Zone II
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 30 Dec 2022
- 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 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: between 16-60 years.
- Flexor tendon injuries of zone II of any medial four digits in both genders.
- within two weeks.
- Sharp mechanism of injury.
- Single-level injury
- Minimal surgical incision.
Who cannot join
- Age less than sixteen years old or more than sixty years old.
- Amputation requiring replantation.
- Vascular injury requiring revascularization
- Associated fractures close to the tendon injury.
- Combined flexor and extensor tendon injury.
- Multiple-level injury
Show all 9Show fewer
- Tendon substance loss
- Insufficient skin and soft tissue coverage.
- Surgical incision for whole tendon exposure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Results Of Repair Of Flexor Tendon In Zone II Using Minimal Incisions, A Case Series Study
Repair of the zone II flexor tendon of the hand using minimal incisions is successful with good results which will improve the outcome of the repair.
Read the detailed description
Flexor tendon laceration in the hand is a common injury with unique characteristics owing to the anatomy of flexor tendons contained within a flexor sheath, requiring good surgical technique as well as strict rehabilitation protocol for regaining function.
The hand is divided into 5 zones (Verdan's). Zone II is described by Bunnel as "No Man's Land" historically back to the 14th century (an area outside London used for executions) because it was previously believed that primary repair should not be done in this zone. After understanding flexor tendon anatomy, biomechanics, and healing new techniques of surgery and anesthesia repair is possible with good results.
Lacerated tendons in zone II can retract proximally to the PIP if the vinculum longus is intact or into the palm if it is disrupted. It will not retract to the level of the wrist because of the origin of the lumbrical insertion into the extensor mechanism.
The laceration can be extended in a Brunner incision or a mid-lateral exposure but it is better skin incisions are minimal to minimize postoperative finger edema, potential adhesions, and injury of any delicate structures.
There are a lot of techniques to retrieve the proximal tendon end as milking, using a hemostat or second incision proximal to the A1 pulley where the tendon is tied to a looped wire of silastic tube and pulled distally through the laceration in the tendon sheath. But little studies discuss the effect of minimal incision on functional outcomes post-operative.
- Conditions
- Flexor Tendon Rupture
- Being tested
- repair of flexor tendon in Zone II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repair of flexor tendon in Zone IIProcedure or surgery
Repair of Zone II flexor tendon of the hand using minimal incisions instead of whole tendon exposure
| Study group | Role | What they receive |
|---|---|---|
| Minimal incisions | Other | Repair of Zone II using minimal incisions Receives: Procedure: repair of flexor tendon in Zone II |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motions
range of motions of fingers using Jamar finger goniometer
Measured: end point 6 months post-operative
Secondary outcomes (3)
complications
as adhesion formation, which limits active range of motion. joint contracture, tendon rupture, triggering, and pulley failure with tendon bowstringin Infection or neuroma
Measured: end point 6 months post-operative
Healing vs failure of repair
questionnaire: can flex finger or not (yes or no)
Measured: baseline
DASH score using DASH questionnaire
Disabilites of the Arm , Shoulder , Hand score (0-100)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Feb 2020
- Primary completion31 Dec 2021
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Flexor Tendon RuptureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Minimal incisions in repair of Zone II flexor tendon of the hand instead of whole exposure of the tendon
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina S. Fekry, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809102
- Sponsor's protocol ID
- Minimal Incisions in Zone II
- Status last verified
- Mar 2023
- First submitted
- 19 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Griffin M, Hindocha S, Jordan D, Saleh M, Khan W. An overview of the management of flexor tendon injuries. Open Orthop J. 2012;6:28-35. doi: 10.2174/1874325001206010028. Epub 2012 Feb 23.
PubMed 22431948Kotwal PP, Ansari MT. Zone 2 flexor tendon injuries: Venturing into the no man's land. Indian J Orthop. 2012 Nov;46(6):608-15. doi: 10.4103/0019-5413.104183.
PubMed 23325961Schoffl V, Heid A, Kupper T. Tendon injuries of the hand. World J Orthop. 2012 Jun 18;3(6):62-9. doi: 10.5312/wjo.v3.i6.62.
PubMed 22720265
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results Of Repair Of Flexor Tendon In Zone II Using Minimal Incisions, A Case Series Study
- ClinicalTrials.gov ID
- NCT05809102
- Acronym / sponsor ID
- Minimal Incisions in Zone II
- Conditions
- Flexor Tendon Rupture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 12 Apr 2023 (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.
Repair of the zone II flexor tendon of the hand using minimal incisions is successful with good results which will improve the outcome of the repair.
Detailed description
Flexor tendon laceration in the hand is a common injury with unique characteristics owing to the anatomy of flexor tendons contained within a flexor sheath, requiring good surgical technique as well as strict rehabilitation protocol for regaining function.
The hand is divided into 5 zones (Verdan's). Zone II is described by Bunnel as "No Man's Land" historically back to the 14th century (an area outside London used for executions) because it was previously believed that primary repair should not be done in this zone. After understanding flexor tendon anatomy, biomechanics, and healing new techniques of surgery and anesthesia repair is possible with good results.
Lacerated tendons in zone II can retract proximally to the PIP if the vinculum longus is intact or into the palm if it is disrupted. It will not retract to the level of the wrist because of the origin of the lumbrical insertion into the extensor mechanism.
The laceration can be extended in a Brunner incision or a mid-lateral exposure but it is better skin incisions are minimal to minimize postoperative finger edema, potential adhesions, and injury of any delicate structures.
There are a lot of techniques to retrieve the proximal tendon end as milking, using a hemostat or second incision proximal to the A1 pulley where the tendon is tied to a looped wire of silastic tube and pulled distally through the laceration in the tendon sheath. But little studies discuss the effect of minimal incision on functional outcomes post-operative.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Minimal incisions in repair of Zone II flexor tendon of the hand instead of whole exposure of the tendon
| Arm | Type | Receives |
|---|---|---|
| Minimal incisions | Other | Procedure: repair of flexor tendon in Zone IIRepair of Zone II using minimal incisions |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age: between 16-60 years.
- Flexor tendon injuries of zone II of any medial four digits in both genders.
- within two weeks.
- Sharp mechanism of injury.
- Single-level injury
Key exclusion criteria (9 listed)
- Age less than sixteen years old or more than sixty years old.
- Amputation requiring replantation.
- Vascular injury requiring revascularization
- Associated fractures close to the tendon injury.
- Combined flexor and extensor tendon injury.
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 |
|---|---|---|
| repair of flexor tendon in Zone IIRepair of Zone II flexor tendon of the hand using minimal incisions instead of whole tendon exposure | Procedure or surgery | Minimal incisions |
Primary outcome
range of motions
Time frame: end point 6 months post-operative
range of motions of fingers using Jamar finger goniometer
3 secondary outcomes
complications
Time frame: end point 6 months post-operative
Healing vs failure of repair
Time frame: baseline
DASH score using DASH questionnaire
Time frame: 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 12 Apr 2023.
- Background: PubMed 22431948Griffin M, Hindocha S, Jordan D, Saleh M, Khan W. An overview of the management of flexor tendon injuries. Open Orthop J. 2012;6:28-35. doi: 10.2174/1874325001206010028. Epub 2012 Feb 23.
- Background: PubMed 23325961Kotwal PP, Ansari MT. Zone 2 flexor tendon injuries: Venturing into the no man's land. Indian J Orthop. 2012 Nov;46(6):608-15. doi: 10.4103/0019-5413.104183.
- Background: PubMed 22720265Schoffl V, Heid A, Kupper T. Tendon injuries of the hand. World J Orthop. 2012 Jun 18;3(6):62-9. doi: 10.5312/wjo.v3.i6.62.
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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 repair of flexor tendon in Zone II in people with Flexor Tendon Rupture, run by Assiut University at 1 site in Egypt.
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 6 inclusion and 9 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 12 Apr 2023. 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 Egypt. 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?
range of motions (time frame: end point 6 months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05809102, which also lists 3 linked publications.
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 12 Apr 2023.