Hand Tendon InjuryFLEXSTRANDNCT07626190
Comparative Study of Four- and Six-Strand Flexor Tendon Repair in Zone II
A study testing Four strand Repair technique and Six Strand Repair Technique in people with Hand Tendon Injury, run by Allied Hospital Faisalabad at 1 site in Pakistan.
Trial summary
Flexor tendon injuries in Zone 2 of the hand remain challenging because of the need to achieve optimal tendon healing while allowing early mobilization and minimizing complications such as rupture and adhesions. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hand Tendon Injury
- What is being tested?
- Four strand Repair technique and Six Strand Repair Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Jan 2026to 26 Apr 2026
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female participants.
- Age 18 to 50 years.
- Zone II flexor tendon injury of the hand.
- Presentation within one week of injury.
- Willingness to participate and provide informed consent.
- Ability to comply with the postoperative rehabilitation protocol.
Who cannot join
- Injuries that interfere with postoperative rehabilitation.
- Extensive soft tissue damage associated with the tendon injury.
- Previous tendon injury in the same digit or hand region.
- Previous surgery in the same affected area.
- Non-compliance or anticipated inability to comply with the postoperative rehabilitation protocol.
- Evidence of a psychological or personality disorder that may affect participation or outcome assessment.
- Systemic illness that may compromise wound or tendon healing (e.g., uncontrolled diabetes mellitus, connective tissue disorders, severe vascular disease).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Allied Hospital, Faisalabad Medical University
Faisalabad, Punjab Province, 00000
About this study
Official title: Comparison of Six Strand and Four Strand Techniques on the Repair of Injured Flexor Tendons of Zone II of the Hand
Flexor tendon injuries in Zone 2 of the hand remain challenging because of the need to achieve optimal tendon healing while allowing early mobilization and minimizing complications such as rupture and adhesions. Various tendon repair techniques have been described, including four-strand and six-strand core suture methods.
This study aims to compare the functional outcomes and complication rates between four-strand and six-strand flexor tendon repair techniques in patients with Zone 2 flexor tendon injuries.
Read the detailed description
Flexor tendon injuries of Zone 2 are among the most difficult hand injuries to manage because of the complex anatomy and the tendency for adhesion formation and tendon rupture. Advances in tendon repair techniques have focused on increasing repair strength to permit early active mobilization while maintaining tendon gliding.
Four-strand repair techniques have been widely used and provide acceptable tensile strength and clinical outcomes. However, six-strand repair techniques may provide greater biomechanical stability and potentially allow safer early mobilization with lower rupture rates. Despite these theoretical advantages, there remains ongoing debate regarding the superiority of one technique over the other in terms of functional recovery and complication profile.
This prospective comparative study will be conducted in patients presenting with acute Zone 2 flexor tendon injuries of the hand. Eligible patients will undergo tendon repair using either four-strand or six-strand core suture techniques according to study allocation. All patients will follow a standardized postoperative rehabilitation protocol.
Primary outcomes will include functional assessment using total active motion and tendon rupture rates.
The findings of this study may help determine the optimal repair technique for improving functional outcomes in Zone 2 flexor tendon injuries while minimizing complications.
- Conditions
- Hand Tendon Injury
- Being tested
- Four strand Repair technique, Six Strand Repair Technique
- Keywords
- Zone 2 Flexor tendon injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four strand Repair techniqueProcedure or surgery
Repair of Zone 2 flexor tendon injuries using a four-strand core suture tendon repair technique performed under standard operative protocol followed by postoperative rehabilitation.
Six Strand Repair TechniqueProcedure or surgery
Repair of Zone 2 flexor tendon injuries using a six-strand core suture tendon repair technique performed under standard operative protocol followed by postoperative rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Four strand repair group | Experimental | Participants in this group will undergo repair of Zone 2 flexor tendon injuries using the four-strand core suture tendon repair technique followed by standardized postoperative rehabilitation. Receives: Procedure: Four strand Repair technique |
| Six strand repair group | Experimental | Participants in this group will undergo repair of Zone 2 flexor tendon injuries using the six-strand core suture tendon repair technique followed by standardized postoperative rehabilitation. Receives: Procedure: Six Strand Repair Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Outcome according to Tang Criteria
Functional outcome assessed using the Tang classification (Excellent, Good, Fair, Poor) based on total active motion of the injured finger. The higher the Tang score, the better functional outcome.
Measured: Three months after Tendon repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start27 Jan 2026
- Primary completion15 Apr 2026
- Study completion26 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand Tendon InjuryStudies 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
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allied Hospital Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Behram Abbas, Allied Hospital Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626190
- Sponsor's protocol ID
- No.48.ERC/FMU/2025-26/106
- Acronym
- FLEXSTRAND
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Six Strand and Four Strand Techniques on the Repair of Injured Flexor Tendons of Zone II of the Hand
- ClinicalTrials.gov ID
- NCT07626190
- Acronym / sponsor ID
- FLEXSTRAND / No.48.ERC/FMU/2025-26/106
- Conditions
- Hand Tendon Injury
- Keywords
- Zone 2 Flexor tendon injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Allied Hospital FaisalabadUniversity, hospital or other
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 26 Apr 2026 (actual)
- First posted
- 4 Jun 2026 (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.
Flexor tendon injuries in Zone 2 of the hand remain challenging because of the need to achieve optimal tendon healing while allowing early mobilization and minimizing complications such as rupture and adhesions. Various tendon repair techniques have been described, including four-strand and six-strand core suture methods.
This study aims to compare the functional outcomes and complication rates between four-strand and six-strand flexor tendon repair techniques in patients with Zone 2 flexor tendon injuries.
Detailed description
Flexor tendon injuries of Zone 2 are among the most difficult hand injuries to manage because of the complex anatomy and the tendency for adhesion formation and tendon rupture. Advances in tendon repair techniques have focused on increasing repair strength to permit early active mobilization while maintaining tendon gliding.
Four-strand repair techniques have been widely used and provide acceptable tensile strength and clinical outcomes. However, six-strand repair techniques may provide greater biomechanical stability and potentially allow safer early mobilization with lower rupture rates. Despite these theoretical advantages, there remains ongoing debate regarding the superiority of one technique over the other in terms of functional recovery and complication profile.
This prospective comparative study will be conducted in patients presenting with acute Zone 2 flexor tendon injuries of the hand. Eligible patients will undergo tendon repair using either four-strand or six-strand core suture techniques according to study allocation. All patients will follow a standardized postoperative rehabilitation protocol.
Primary outcomes will include functional assessment using total active motion and tendon rupture rates.
The findings of this study may help determine the optimal repair technique for improving functional outcomes in Zone 2 flexor tendon injuries while minimizing complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Four strand repair group | Experimental | Procedure: Four strand Repair techniqueParticipants in this group will undergo repair of Zone 2 flexor tendon injuries using the four-strand core suture tendon repair technique followed by standardized postoperative rehabilitation. |
| Six strand repair group | Experimental | Procedure: Six Strand Repair TechniqueParticipants in this group will undergo repair of Zone 2 flexor tendon injuries using the six-strand core suture tendon repair technique followed by standardized postoperative rehabilitation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female participants.
- Age 18 to 50 years.
- Zone II flexor tendon injury of the hand.
- Presentation within one week of injury.
- Willingness to participate and provide informed consent.
Key exclusion criteria (7 listed)
- Injuries that interfere with postoperative rehabilitation.
- Extensive soft tissue damage associated with the tendon injury.
- Previous tendon injury in the same digit or hand region.
- Previous surgery in the same affected area.
- Non-compliance or anticipated inability to comply with the postoperative rehabilitation protocol.
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 |
|---|---|---|
| Four strand Repair techniqueRepair of Zone 2 flexor tendon injuries using a four-strand core suture tendon repair technique performed under standard operative protocol followed by postoperative rehabilitation. | Procedure or surgery | Four strand repair group |
| Six Strand Repair TechniqueRepair of Zone 2 flexor tendon injuries using a six-strand core suture tendon repair technique performed under standard operative protocol followed by postoperative rehabilitation. | Procedure or surgery | Six strand repair group |
Primary outcome
Functional Outcome according to Tang Criteria
Time frame: Three months after Tendon repair
Functional outcome assessed using the Tang classification (Excellent, Good, Fair, Poor) based on total active motion of the injured finger. The higher the Tang score, the better functional outcome.
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 4 Jun 2026.
- Individual participant dataSharing planned: No. No, individual participant data will not be shared.
Related trials for Hand Tendon Injury
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Ultrasound-Guided Repeated Saline Injections to Prevent and Treat Tendon Adhesions After Hand Tendon Repair
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3D Hand Orthosis Trial
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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 Four strand Repair technique and Six Strand Repair Technique in people with Hand Tendon Injury, run by Allied Hospital Faisalabad at 1 site in Pakistan.
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 7 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 4 Jun 2026. 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 Pakistan. 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?
Functional Outcome according to Tang Criteria (time frame: Three months after Tendon repair). 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 4 Jun 2026.