Repair of Flexor Tendon Injuries With Eight Strand Core Stitch Without Postoperative Splinting

NCT ID: NCT03938935

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2021-08-31

Brief Summary

Evaluation of early active postoperative mobilisation in flexor tendon injuries without postoperative splinting

Detailed Description

Flexor tendon injuries are a common event as the tendons lie close to the skin and so are usually the result of either lacerations such as those from knives or glass, from crush injuries and occasionally they can rupture from where they are joined at the bone during contact sports such as football, rugby and wrestling. Flexor tendon injuries are a challenging problem for orthopaedic surgeons due to three main reasons. Firstly, flexor tendon injuries of the hands are a clinical problem because they cannot heal without surgical treatment, as the two ends need to be surgically brought together for the healing to occur unlike other tendons including the Achilles tendon where it could be placed into plantar flexion to heal. Secondly postoperative management needs to be carefully planned as mobilisation has shown to be essential to prevent adhesions and improve gliding but this can risk rupture. Lastly due to the unique anatomy of the tendons running through flexor tendon sheaths to function, surgeons need to plan preventing increasing the bulkiness of the tendon through its sheath, which is not always possible from scarring as this affects the functional outcome of the tendon

-_ The ultimate goal of surgical intervention has remained constant: to achieve enough strength to allow early motion, to prevent adhesions within the tendon sheath, and to restore the finger to normal range of motion and function.

• The successful repair requires minimal gapping at the repair site or interference with tendon vascularity, secure suture knots, smooth junction of tendon end and having sufficient strength for healing.
• The strength of the core suture is one of the important factors for valid flexor tendon repair. It is obvious that an increased strand number increases repair gap resistance and strength

Conditions

Flexor Tendon Repair

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Absorbable polydioxanone suture (PDS)

PDS is a Polydioxanone synthetic monofilament which is absorbable.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Adult patient ( > 16 years)

2. Flexor tendon injuries zones (II,III,IV,V)

Exclusion Criteria

1. Patients < 16 years

2. Flexor tendon injuries zone I

2- Fracture of hand,wrist or forearm bones 3- Associated nerve injuries

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mina Micheal Anwer Fahmy

OTHER

Sponsor Role: lead

Responsible Party

Mina Micheal Anwer Fahmy

Resident of Trauma and Orthopedic surgery-Assiut university

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Mina Micheal Anwer, MBBCh

Role: CONTACT

minamicheeal@gmail.com

01023428667

Yasser Mohamed Farouk, MD

Role: CONTACT

yasserragheb@yahoo.com

01015808000

References

Myer C, Fowler JR. Flexor Tendon Repair: Healing, Biomechanics, and Suture Configurations. Orthop Clin North Am. 2016 Jan;47(1):219-26. doi: 10.1016/j.ocl.2015.08.019.

Reference Type: BACKGROUND

PMID: 26614935 (View on PubMed)

Other Identifiers

Repair of flexor tendon injury

Identifier Type: -

Identifier Source: org_study_id