Results of 8 Strand Repair of Flexor Tendon Injuries

Not Applicable

Not yet recruiting

• Conditions: Cut Flexor Zone ll Using 8-strand
• Interventions: Procedure: Repair of flexor tendon injury zone ll using 8- strand

• Registration Number: NCT06504680
• Lead Sponsor: Assiut University

Brief Summary

Functional results of 8 strand repair of flexor tendon injuries zone II with and without splinting of the wrist

Detailed Description

Flexor tendon injuries of the hand, account for 30% of all hand injuries, but are difficult to treat and are associated with frequent poor outcomes . While major progress has been made with the treatment of these injuries, current surgical treatment relies mostly on conventional suturing techniques with variable results, concluding in re-operation rates of 12%, and complication rate of up to 20% Restoration of tendon gliding is the goal when repairing flexor tendon injuries. The tendon forces experienced during postoperative, active flexion exercises are significantly larger than the tendon forces experienced by patients engaging in only passive flexion. Multistrand sutures (typically four- or six-strand repairs) may withstand much greater tension than conventional two-strand sutures during early active mobilization.

However, multistrand (particularly eight-strand) repair requires complicated surgical skills; such repair is difficult. Here, we present a new eight-strand suture for flexor tendon repair that features easier passages through the tendons and fewer knots than existing approaches; it affords the necessary tensile strength to prevent both gap formation and ultimate failure.

The important aspects of flexor tendon repair are that the suture should have sufficient mechanical strength, and it should not result in a bulky configuration, which would affect tendon gliding .

Using the 8-strand repair technique and active mobilization performed by the patient is both practical and cost-saving. Intensive supervision of a hand therapist is generally not required. Notably improved outcomes have been achieved while preventing adhesions at the repair site.

Study Timeline

• Study First Submitted: 2024-04-03
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-15
• Last Update Submitted: 2024-07-15
• Study First Posted: 2024-07-17
• Last Update Posted: 2024-07-17
• Study Start: 2024-08-10
• Primary Completion: 2025-04
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Splinted cases	Repair of flexor tendon injury zone ll using 8- strand	Repair cut flexor zone ll using 8-strand with splint the wrist
Non splinting cases	Repair of flexor tendon injury zone ll using 8- strand	Repair cut flexor zone ll using 8-strand without splint the wrist

Primary Outcome Measures

Name	Time	Method
range of motion	Six month post operative	ROM using Strickland criteria by finger goniometer

Secondary Outcome Measures

Name	Time	Method
Hand function	6 month post-operative	Hand function using DASH score
Complications	6 month post-operative	As rupture , adhesion