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NCT Number: NCT07626190

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

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allied Hospital, Faisalabad Medical University

Faisalabad, Punjab Province, 00000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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).

Treatment and study plan

Four strand Repair technique

Procedure

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 Technique

Procedure

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Allied Hospital Faisalabad

Other

Registry information

Official study title

Comparison of Six Strand and Four Strand Techniques on the Repair of Injured Flexor Tendons of Zone II of the Hand

Acronym: FLEXSTRAND

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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