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CompletedNCT07626190FLEXSTRANDUpdated Jun 4, 2026

Comparative Study of Four- and Six-Strand Flexor Tendon Repair in Zone II

An interventional study of Four strand Repair technique and Six Strand Repair Technique in Hand Tendon Injury, sponsored by Allied Hospital Faisalabad. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Allied Hospital Faisalabad · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2026, registered May 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hand Tendon Injury

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Keywords

  • Zone 2 Flexor tendon injuries
03

In context

Tendon Injuries

100 studies on the registry are indexed under Tendon Injuries; 27 are open to participants now.

This study's enrollment of 136 is above the median of 44 across 70 interventional studies indexed under Tendon Injuries.

Browse Tendon Injuries studies →

Lead sponsor

Allied Hospital Faisalabad is the lead sponsor of 11 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .
  • Ability to comply with the postoperative rehabilitation protocol.

Exclusion criteria

Exclusion Criteria:

  • 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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
136 participants (actual)

Study arms

  • Experimental
    Four strand repair group

    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.

    Procedure: Four strand Repair technique

  • Experimental
    Six strand repair group

    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.

    Procedure: Six Strand Repair Technique

Interventions

  • ProcedureFour strand Repair technique

    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.

  • ProcedureSix Strand Repair Technique

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Three months after Tendon repair

07

Study locations

1 site
  • Allied Hospital, Faisalabad Medical University
    Faisalabad, Punjab Province 00000, Pakistan
08

References and documents

Individual participant data

Plan to share: No — No, individual participant data will not be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07626190
Lead sponsor
Allied Hospital Faisalabad
Responsible party
Muhammad Behram Abbas (Post Graduate Resident, Department of Plastic Surgery, Allied Hospital Faisalabad) — Principal investigator
First posted
Jun 4, 2026
Start date
Jan 27, 2026
Primary completion
Apr 15, 2026
Completion
Apr 26, 2026
Last update
Jun 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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