CClinicalTrials.gg
Status unknownNCT03938935Updated May 7, 2019

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

An interventional study of Absorbable polydioxanone suture (PDS) in Flexor Tendon Repair, sponsored by Mina Micheal Anwer Fahmy. Status unknown. Open to participants aged 16 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-07.

Sponsored by Mina Micheal Anwer Fahmy · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
16 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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
02

Conditions studied

  • Flexor Tendon Repair

Browse trials for

03

In context

Tendon Injuries

92 studies on the registry are indexed under Tendon Injuries; 15 are open to participants now.

This study's planned enrollment of 1 is below the median of 40 across 64 interventional studies indexed under Tendon Injuries.

Browse Tendon Injuries studies →

Lead sponsor

This is the only study on the registry with Mina Micheal Anwer Fahmy as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Adult patient ( > 16 years)
  2. Flexor tendon injuries zones (II,III,IV,V)

Exclusion criteria

Exclusion Criteria:

  1. Patients \< 16 years
  2. Flexor tendon injuries zone I

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
1 participant (estimated)

Interventions

  • ProcedureAbsorbable polydioxanone suture (PDS)

    PDS is a Polydioxanone synthetic monofilament which is absorbable.

06

What researchers measure

Primary outcomes

  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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 26614935 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03938935
Lead sponsor
Mina Micheal Anwer Fahmy
Responsible party
Mina Micheal Anwer Fahmy (Resident of Trauma and Orthopedic surgery-Assiut university, Assiut University) — Sponsor-investigator
First posted
May 6, 2019
Start date
Oct 2019 (estimated)
Primary completion
Feb 2021 (estimated)
Completion
Aug 2021 (estimated)
Last update
May 7, 2019

Study contacts

Mina Micheal Anwer, MBBCh
Contact
minamicheeal@gmail.com
01023428667
Yasser Mohamed Farouk, MD
Contact
yasserragheb@yahoo.com
01015808000

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion