Results of 8 Strand Repair of Flexor Tendon Injuries

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cut Flexor Zone ll Using 8-strand
• Intervention / Treatment: Procedure: Repair of flexor tendon injury zone ll using 8- strand

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 Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mostafa Mahmoud; Phone Number: 01003046736; Email: mustafa100100@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Adult patient
2. No fractures in the affected finger
3. Thumb is excluded
4. Duration of injury less than 2 weeks

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Splinted cases; Repair cut flexor zone ll using 8-strand with splint the wrist	Procedure: Repair of flexor tendon injury zone ll using 8- strand; Repair cut flexor zone ll using 8-strand with and without splinting the wrist
Active Comparator: Non splinting cases; Repair cut flexor zone ll using 8-strand without splint the wrist	Procedure: Repair of flexor tendon injury zone ll using 8- strand; Repair cut flexor zone ll using 8-strand with and without splinting the wrist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
range of motion	ROM using Strickland criteria by finger goniometer	Six month post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand function	Hand function using DASH score	6 month post-operative
Complications	As rupture , adhesion	6 month post-operative

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General 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 record dates

Study Major Dates

• Study Start (Estimated): August 10, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Tendon Injuries
• Other Study ID Numbers: Cut flexor zone ll

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No