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NCT Number: NCT06504680

Results of 8 Strand Repair of Flexor Tendon Injuries

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

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Key information

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patient
  • No fractures in the affected finger
  • Thumb is excluded
  • Duration of injury less than 2 weeks

Exclusion criteria

-

Treatment and study plan

Repair of flexor tendon injury zone ll using 8- strand

Procedure

Repair cut flexor zone ll using 8-strand with and without splinting the wrist

Primary outcomes

  1. range of motion

    Time frame: Six month post operative

    ROM using Strickland criteria by finger goniometer

Secondary outcomes

  1. Hand function

    Time frame: 6 month post-operative

    Hand function using DASH score

  2. Complications

    Time frame: 6 month post-operative

    As rupture , adhesion

Study contacts

Contact information is provided by the study sponsor or research team.

Mostafa Mahmoud

CONTACT

[email protected]

01003046736

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Results of 8 Strand Repair of Flexor Tendon Injuries Zone II With and Without Splinting of the Wrist A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2024
Registry last updated
Jul 17, 2024

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.