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

Allied Hospital Faisalabad

Status: Completed

Conditions: Hand Tendon Injury

Treatments: Procedure: Six Strand Repair Technique; Procedure: Four strand Repair technique

Study type: Interventional

Funder types: Other

Identifiers

NCT07626190

No.48.ERC/FMU/2025-26/106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Four strand repair group

Experimental group

Description:

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.

Treatment:

Procedure: Four strand Repair technique

Six strand repair group

Experimental group

Description:

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.

Treatment:

Procedure: Six Strand Repair Technique