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Repair of Flexor Tendon Injuries With Eight Strand Core Stitch Without Postoperative Splinting
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Flexor Tendon Repair | Procedure: Absorbable polydioxanone suture (PDS) | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| 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 |
- 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 ]
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 3, 2019 | ||||||||
| First Posted Date ICMJE | May 6, 2019 | ||||||||
| Last Update Posted Date | May 7, 2019 | ||||||||
| Estimated Study Start Date ICMJE | October 2019 | ||||||||
| Estimated Primary Completion Date | February 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Repair of Flexor Tendon Injuries With Eight Strand Core Stitch Without Postoperative Splinting | ||||||||
| Official Title ICMJE | Repair of Flexor Tendon Injuries With Eight Strand Core Stitch Without Postoperative Splinting | ||||||||
| 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.
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Flexor Tendon Repair | ||||||||
| Intervention ICMJE | Procedure: Absorbable polydioxanone suture (PDS)
PDS is a Polydioxanone synthetic monofilament which is absorbable.
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| Study Arms ICMJE | Not Provided | ||||||||
| 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. Review. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE |
1 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | August 2021 | ||||||||
| Estimated Primary Completion Date | February 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
2- Fracture of hand,wrist or forearm bones 3- Associated nerve injuries |
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| Sex/Gender ICMJE |
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| Ages ICMJE | 16 Years to 70 Years (Child, Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Not Provided | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03938935 | ||||||||
| Other Study ID Numbers ICMJE | Repair of flexor tendon injury | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Mina Micheal Anwer Fahmy, Assiut University | ||||||||
| Study Sponsor ICMJE | Mina Micheal Anwer Fahmy | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Assiut University | ||||||||
| Verification Date | May 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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