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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07626190
Acronym
FLEXSTRAND
Enrollment
136
Registered
2026-06-04
Start date
2026-01-27
Completion date
2026-04-26
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Tendon Injury

Keywords

Zone 2 Flexor tendon injuries

Brief 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.

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.

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.

Sponsors

Allied Hospital Faisalabad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Functional Outcome according to Tang CriteriaThree months after Tendon repairFunctional 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026