Repair of Flexor Tendon Injuries With Eight Strand Core Stitch Without Postoperative Splinting
Primary Purpose
Flexor Tendon Repair
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Absorbable polydioxanone suture (PDS)
Sponsored by

About this trial
This is an interventional treatment trial for Flexor Tendon Repair
Eligibility Criteria
Inclusion Criteria:
- Adult patient ( > 16 years)
- Flexor tendon injuries zones (II,III,IV,V)
Exclusion Criteria:
- Patients < 16 years
- Flexor tendon injuries zone I
2- Fracture of hand,wrist or forearm bones 3- Associated nerve injuries
Sites / Locations
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03938935
Brief Title
Repair of Flexor Tendon Injuries With Eight Strand Core Stitch Without Postoperative Splinting
Official Title
Repair of Flexor Tendon Injuries With Eight Strand Core Stitch Without Postoperative Splinting
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2019 (Anticipated)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mina Micheal Anwer Fahmy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flexor Tendon Repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Absorbable polydioxanone suture (PDS)
Intervention Description
PDS is a Polydioxanone synthetic monofilament which is absorbable.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult patient ( > 16 years)
Flexor tendon injuries zones (II,III,IV,V)
Exclusion Criteria:
Patients < 16 years
Flexor tendon injuries zone I
2- Fracture of hand,wrist or forearm bones 3- Associated nerve injuries
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mina Micheal Anwer, MBBCh
Phone
01023428667
Email
minamicheeal@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yasser Mohamed Farouk, MD
Phone
01015808000
Email
yasserragheb@yahoo.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
26614935
Citation
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.
Results Reference
background
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Repair of Flexor Tendon Injuries With Eight Strand Core Stitch Without Postoperative Splinting
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