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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03938935

Recruitment Status Not yet recruiting

First Posted May 6, 2019

Last update posted May 7, 2019

Study Description

Brief summary:

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

  • Condition or Disease:Flexor Tendon Repair
  • Intervention/Treatment: Procedure: Absorbable polydioxanone suture (PDS)
  • Phase: N/A
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

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 1 participants
  • Allocation: Randomized
  • Intervention Model: Single Group Assignment
  • Masking: Single (Investigator)
  • Primary Purpose: Treatment
  • Official Title: Repair of Flexor Tendon Injuries With Eight Strand Core Stitch Without Postoperative Splinting
  • Estimated Study Start Date: October 2019
  • Estimated Primary Completion Date: February 2021
  • Estimated Study Completion Date: August 2021
Outcome Measures
  • Primary Outcome Measures: 1. Early postoperative mobilisation of fingers (active & passive) - Follow up will be done according to DASH (Disability of arm,shoulder and hand) score at 6 weeks [ Time Frame: one and half month ]
Eligibility Criteria
  • Ages Eligible for Study: 16 to 70 Years (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contact: Mina Micheal Anwer, MBBCh 01023428667 minamicheeal@gmail.com

Contact: Yasser Mohamed Farouk, MD 01015808000 yasserragheb@yahoo.com

Sponsors and Collaborators

Mina Micheal Anwer Fahmy

More Information