Cut Flexor Zone ll Using 8-strandNCT06504680
Results of 8 Strand Repair of Flexor Tendon Injuries
A study testing Repair of flexor tendon injury zone ll using 8- strand in people with Cut Flexor Zone ll Using 8-strand, run by Assiut University.
Trial summary
Functional results of 8 strand repair of flexor tendon injuries zone II with and without splinting of the wrist Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Cut Flexor Zone ll Using 8-strand
- What is being tested?
- Repair of flexor tendon injury zone ll using 8- strand
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2024to Jun 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adult patient
- No fractures in the affected finger
- Thumb is excluded
- Duration of injury less than 2 weeks
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Results of 8 Strand Repair of Flexor Tendon Injuries Zone II With and Without Splinting of the Wrist A Randomized Controlled Trial
Functional results of 8 strand repair of flexor tendon injuries zone II with and without splinting of the wrist
Read the detailed description
Flexor tendon injuries of the hand, account for 30% of all hand injuries, but are difficult to treat and are associated with frequent poor outcomes . While major progress has been made with the treatment of these injuries, current surgical treatment relies mostly on conventional suturing techniques with variable results, concluding in re-operation rates of 12%, and complication rate of up to 20% Restoration of tendon gliding is the goal when repairing flexor tendon injuries. The tendon forces experienced during postoperative, active flexion exercises are significantly larger than the tendon forces experienced by patients engaging in only passive flexion. Multistrand sutures (typically four- or six-strand repairs) may withstand much greater tension than conventional two-strand sutures during early active mobilization.
However, multistrand (particularly eight-strand) repair requires complicated surgical skills; such repair is difficult. Here, we present a new eight-strand suture for flexor tendon repair that features easier passages through the tendons and fewer knots than existing approaches; it affords the necessary tensile strength to prevent both gap formation and ultimate failure.
The important aspects of flexor tendon repair are that the suture should have sufficient mechanical strength, and it should not result in a bulky configuration, which would affect tendon gliding .
Using the 8-strand repair technique and active mobilization performed by the patient is both practical and cost-saving. Intensive supervision of a hand therapist is generally not required. Notably improved outcomes have been achieved while preventing adhesions at the repair site.
- Conditions
- Cut Flexor Zone ll Using 8-strand
- Being tested
- Repair of flexor tendon injury zone ll using 8- strand
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair of flexor tendon injury zone ll using 8- strandProcedure or surgery
Repair cut flexor zone ll using 8-strand with and without splinting the wrist
| Study group | Role | What they receive |
|---|---|---|
| Splinted cases | Active comparator | Repair cut flexor zone ll using 8-strand with splint the wrist Receives: Procedure: Repair of flexor tendon injury zone ll using 8- strand |
| Non splinting cases | Active comparator | Repair cut flexor zone ll using 8-strand without splint the wrist Receives: Procedure: Repair of flexor tendon injury zone ll using 8- strand |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion
ROM using Strickland criteria by finger goniometer
Measured: Six month post operative
Secondary outcomes (2)
Hand function
Hand function using DASH score
Measured: 6 month post-operative
Complications
As rupture , adhesion
Measured: 6 month post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start10 Aug 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionJun 2025 (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 Cut Flexor Zone ll Using 8-strandStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mahmoud Mohamed Abdelrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504680
- Sponsor's protocol ID
- Cut flexor zone ll
- Status last verified
- Jul 2024
- First submitted
- 3 Apr 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1.Rigo IZ, Røkkum M. Predictors of outcome after primary flexor tendon repair in zone 1, 2 and 3. J Hand Surg Eur. 2016;41:793-801. https://doi.org/10.1177/1753193416657758. Article CAS Google Scholar 2.Dy CJ, Hernandez-Soria A, Ma Y, Roberts TR, Daluiski A. Complications after flexor tendon repair: a systematic review and meta-analysis. J Hand Surg Am. 2012;37:543-551.e1. https://doi.org/10.1016/j.jhsa.2011.11.006. Article PubMed Google Scholar 3.Ishak A, Rajangam A, Khajuria A. The evidence-base for the management of flexor tendon injuries of the hand: review. Ann Med Surg. 2019;48:1-6. https://doi.org/10.1016/j.amsu.2019.10.006. Article CAS Google Scholar 4.Dy CJ, Lyman S, Schreiber JJ, Do HT, Daluiski A. The epidemiology of reoperation after flexor pulley reconstruction. J Hand Surg Am. 2013. https://doi.org/10.1016/j.jhsa.2013.05.015. Article PubMed PubMed Central Google Scholar 5.Dy CJ, Daluiski A. Update on zone II flexor tendon injuries. J Am Acad Orthop Surg. 2014. https://doi.org/10.5435/JAAOS-22-12-791. 6. Silfverskiöld K L, May E J. Flexor tendon repair in zone II with a new suture technique and an early mobilization program combining passive and active flexion. J Hand Surg Am. 1994;19(01):53-60. [PubMed] [Google Scholar] 7. Moriya K, Yoshizu T, Maki Y, Tsubokawa N, Narisawa H, Endo N. Clinical outcomes of early active mobilization following flexor tendon repair using the six-strand technique: short- and long-term evaluations. J Hand Surg Eur Vol. 2015;40(03):250-258. [PubMed] [Google Scholar] 8. Tang J B, Zhou X, Pan Z J, Qing J, Gong K T, Chen J. Strong digital flexor tendon repair, extension-flexion test, and early active flexion: experience in 300 tendons. Hand Clin. 2017;33(03):455-463. [PubMed] [Google Scholar] 9. Sandow M J, McMahon M M. Single-cross grasp six-strand repair for acute flexor tenorrhaphy: modified Savage technique. Atlas Hand Clin. 1996;1(01):41-64. [Google Scholar] 10. Yoshizu T.Immediate mobilization following flexor tendon repair(in Japanese)J Musculoskelet Syst 1996908881-890. [Google Scholar] 11. Croog A, Goldstein R, Nasser P, et al. Comparative biomechanic performances of locked cruciate four-strand flexor tendon repairs in an ex vivo porcine model. J Hand Surg Am. 2007;32:225-232. [PubMed] [Google Scholar] 12. Jordan MC, Schmitt V, Jansen H, et al. Biomechanical analysis of the modified Kessler, Lahey, Adelaide, and Becker sutures for flexor tendon repair. J Hand Surg Am. 2015;40:1812-1817. [PubMed] [Google Scholar] 13. Tarek Abdalla El-Gammal https://orcid.org/0000-0002-8434-3523 tarek.elgammal@aun.edu.eg, Mohamed Mostafa Kotb, […], and Mina Micheal Anwar+2View all authors and affiliations OnlineFirst: Outcome of Flexor Tendon Repair Using Eight-Strand Core Stitch Without Postoperative Finger Splinting, https://doi.org/10.1177/15589447231220686
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of 8 Strand Repair of Flexor Tendon Injuries Zone II With and Without Splinting of the Wrist A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06504680
- Acronym / sponsor ID
- Cut flexor zone ll
- Conditions
- Cut Flexor Zone ll Using 8-strand
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 17 Jul 2024 (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.
Functional results of 8 strand repair of flexor tendon injuries zone II with and without splinting of the wrist
Detailed description
Flexor tendon injuries of the hand, account for 30% of all hand injuries, but are difficult to treat and are associated with frequent poor outcomes . While major progress has been made with the treatment of these injuries, current surgical treatment relies mostly on conventional suturing techniques with variable results, concluding in re-operation rates of 12%, and complication rate of up to 20% Restoration of tendon gliding is the goal when repairing flexor tendon injuries. The tendon forces experienced during postoperative, active flexion exercises are significantly larger than the tendon forces experienced by patients engaging in only passive flexion. Multistrand sutures (typically four- or six-strand repairs) may withstand much greater tension than conventional two-strand sutures during early active mobilization.
However, multistrand (particularly eight-strand) repair requires complicated surgical skills; such repair is difficult. Here, we present a new eight-strand suture for flexor tendon repair that features easier passages through the tendons and fewer knots than existing approaches; it affords the necessary tensile strength to prevent both gap formation and ultimate failure.
The important aspects of flexor tendon repair are that the suture should have sufficient mechanical strength, and it should not result in a bulky configuration, which would affect tendon gliding .
Using the 8-strand repair technique and active mobilization performed by the patient is both practical and cost-saving. Intensive supervision of a hand therapist is generally not required. Notably improved outcomes have been achieved while preventing adhesions at the repair site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Splinted cases | Active comparator | Procedure: Repair of flexor tendon injury zone ll using 8- strandRepair cut flexor zone ll using 8-strand with splint the wrist |
| Non splinting cases | Active comparator | Procedure: Repair of flexor tendon injury zone ll using 8- strandRepair cut flexor zone ll using 8-strand without splint the wrist |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adult patient
- No fractures in the affected finger
- Thumb is excluded
- Duration of injury less than 2 weeks
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Repair of flexor tendon injury zone ll using 8- strandRepair cut flexor zone ll using 8-strand with and without splinting the wrist | Procedure or surgery | Non splinting cases, Splinted cases |
Primary outcome
range of motion
Time frame: Six month post operative
ROM using Strickland criteria by finger goniometer
2 secondary outcomes
Hand function
Time frame: 6 month post-operative
Complications
Time frame: 6 month post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Background1.Rigo IZ, Røkkum M. Predictors of outcome after primary flexor tendon repair in zone 1, 2 and 3. J Hand Surg Eur. 2016;41:793-801. https://doi.org/10.1177/1753193416657758. Article CAS Google Scholar 2.Dy CJ, Hernandez-Soria A, Ma Y, Roberts TR, Daluiski A. Complications after flexor tendon repair: a systematic review and meta-analysis. J Hand Surg Am. 2012;37:543-551.e1. https://doi.org/10.1016/j.jhsa.2011.11.006. Article PubMed Google Scholar 3.Ishak A, Rajangam A, Khajuria A. The evidence-base for the management of flexor tendon injuries of the hand: review. Ann Med Surg. 2019;48:1-6. https://doi.org/10.1016/j.amsu.2019.10.006. Article CAS Google Scholar 4.Dy CJ, Lyman S, Schreiber JJ, Do HT, Daluiski A. The epidemiology of reoperation after flexor pulley reconstruction. J Hand Surg Am. 2013. https://doi.org/10.1016/j.jhsa.2013.05.015. Article PubMed PubMed Central Google Scholar 5.Dy CJ, Daluiski A. Update on zone II flexor tendon injuries. J Am Acad Orthop Surg. 2014. https://doi.org/10.5435/JAAOS-22-12-791. 6. Silfverskiöld K L, May E J. Flexor tendon repair in zone II with a new suture technique and an early mobilization program combining passive and active flexion. J Hand Surg Am. 1994;19(01):53-60. [PubMed] [Google Scholar] 7. Moriya K, Yoshizu T, Maki Y, Tsubokawa N, Narisawa H, Endo N. Clinical outcomes of early active mobilization following flexor tendon repair using the six-strand technique: short- and long-term evaluations. J Hand Surg Eur Vol. 2015;40(03):250-258. [PubMed] [Google Scholar] 8. Tang J B, Zhou X, Pan Z J, Qing J, Gong K T, Chen J. Strong digital flexor tendon repair, extension-flexion test, and early active flexion: experience in 300 tendons. Hand Clin. 2017;33(03):455-463. [PubMed] [Google Scholar] 9. Sandow M J, McMahon M M. Single-cross grasp six-strand repair for acute flexor tenorrhaphy: modified Savage technique. Atlas Hand Clin. 1996;1(01):41-64. [Google Scholar] 10. Yoshizu T.Immediate mobilization following flexor tendon repair(in Japanese)J Musculoskelet Syst 1996908881-890. [Google Scholar] 11. Croog A, Goldstein R, Nasser P, et al. Comparative biomechanic performances of locked cruciate four-strand flexor tendon repairs in an ex vivo porcine model. J Hand Surg Am. 2007;32:225-232. [PubMed] [Google Scholar] 12. Jordan MC, Schmitt V, Jansen H, et al. Biomechanical analysis of the modified Kessler, Lahey, Adelaide, and Becker sutures for flexor tendon repair. J Hand Surg Am. 2015;40:1812-1817. [PubMed] [Google Scholar] 13. Tarek Abdalla El-Gammal https://orcid.org/0000-0002-8434-3523 tarek.elgammal@aun.edu.eg, Mohamed Mostafa Kotb, […], and Mina Micheal Anwar+2View all authors and affiliations OnlineFirst: Outcome of Flexor Tendon Repair Using Eight-Strand Core Stitch Without Postoperative Finger Splinting, https://doi.org/10.1177/15589447231220686
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 Repair of flexor tendon injury zone ll using 8- strand in people with Cut Flexor Zone ll Using 8-strand, run by Assiut University.
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 4 inclusion and 1 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 17 Jul 2024. 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 Mostafa Mahmoud (01003046736, mustafa100100@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
range of motion (time frame: Six month post operative). 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 NCT06504680, 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 17 Jul 2024.