Flexor Tendon RepairNCT03938935
Repair of Flexor Tendon Injuries With Eight Strand Core Stitch Without Postoperative Splinting
A study testing Absorbable polydioxanone suture (PDS) in people with Flexor Tendon Repair, run by Mina Micheal Anwer Fahmy.
Trial summary
Evaluation of early active postoperative mobilisation in flexor tendon injuries without postoperative splinting Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Flexor Tendon Repair
- What is being tested?
- Absorbable polydioxanone suture (PDS)
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult patient ( > 16 years)
- Flexor tendon injuries zones (II,III,IV,V)
Who cannot join
- Patients < 16 years
- Flexor tendon injuries zone I
- 2- Fracture of hand,wrist or forearm bones 3- Associated nerve injuries
Trial locations and contacts
No sites are listed yet.
About this study
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
- Conditions
- Flexor Tendon Repair
- Being tested
- Absorbable polydioxanone suture (PDS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbable polydioxanone suture (PDS)Procedure or surgery
PDS is a Polydioxanone synthetic monofilament which is absorbable.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one and half month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study startOct 2019 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Flexor Tendon RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mina Micheal Anwer Fahmy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mina Micheal Anwer Fahmy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938935
- Sponsor's protocol ID
- Repair of flexor tendon injury
- Status last verified
- May 2019
- First submitted
- 3 May 2019
- Last updated
- 7 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repair of Flexor Tendon Injuries With Eight Strand Core Stitch Without Postoperative Splinting
- ClinicalTrials.gov ID
- NCT03938935
- Acronym / sponsor ID
- Repair of flexor tendon injury
- Conditions
- Flexor Tendon Repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Mina Micheal Anwer FahmyUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patient ( > 16 years)
- Flexor tendon injuries zones (II,III,IV,V)
Key exclusion criteria (3 listed)
- Patients < 16 years
- Flexor tendon injuries zone I
- 2- Fracture of hand,wrist or forearm bones 3- Associated nerve injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Absorbable polydioxanone suture (PDS)PDS is a Polydioxanone synthetic monofilament which is absorbable. | Procedure or surgery | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Background: PubMed 26614935Myer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Absorbable polydioxanone suture (PDS) in people with Flexor Tendon Repair, run by Mina Micheal Anwer Fahmy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mina Micheal Anwer, MBBCh (01023428667, minamicheeal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03938935, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.