Eendoscopic Versus Open Flexor Hallucis Longus Transfer in Managing Various Tendon Achilles Disorders

NCT06639308 | Active Not Recruiting DMC

• 1 other identifier: IRB 04-2024-100267
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

• A well-established protocol for the treatment or augmentation a wide range of Achilles disorders including chronic Achilles tendon (AT) rupture, Achilles insertional tendinopathy, Haglund syndrome and among others, is a Flexor hallucis longus (FHL) tendon transfer (1-4).
• Long incisions are required for open surgical procedures, which increase the risk of skin breakdown and wound infection. These factors have contributed to the increased use of endoscopy in the surgical treatment of different Achilles pathologies. Compared to open methods, endoscopic techniques provided the advantage of managing pathology with a low risk of soft-tissue complications(4-7).
• It has been recommended to use an FHL transfer. (8-10) Its anatomic proximity prevents iatrogenic lesions of the neurovascular bundle, it fires in phase with the gastrocnemius-soleus complex, it is a stronger plantar flexor, and its axis of contractile force more closely looks similar to that of the AT. It is plantar flexion strength reinforcement, which is almost always compromised with fascial advancement alone(11). Regarding the nature of the AT's vascularization, the FHL muscle belly reaches distally into its avascular zone, which allows the repaired AT to be recruitment of an increased blood supply. Moreover, by moving muscles that perform the same function, FHL transfer preserves the ankle's natural muscular balance. (8) A recent study using magnetic resonance imaging evaluation revealed that in 60% of patients, the FHL tendon had fully integrated, and in 80% of patients, there was hypertrophy of the tendon above 15%.
• This study tends to compare the outcomes of both open and endoscopic FHL transfer in different parameters like functional outcome, wound complication, and accelerated rehabilitation.
• This is a Prospective, randomized control trial. The study will be conducted on 30 patients complaining of chronic Achilles tendon rupture, Achilles insertional tendinopathy, Haglund syndrome planned for FHL transfer in Assiut university hospital. Patients will be randomized to two groups one group endoscopic FHL will be conducted in other hand second group open FHL will be conducted. The PICOT algorithm was preliminarily pointed out:
• P (Problem): Different Achilles disorders such as chronic Achilles tendon (AT) rupture, Achilles insertional tendinopathy, Haglund syndrome and among others.
• I (Intervention): Endoscopic FHL Transfer.
• C (Comparison): open FHL tendon transfers.
• O (Outcomes): Clinical outcomes, complications, and return to sport.
• T (Timing): ≥6 months of follow-up. Preoperative assessment: A- Detailed history and examination:
• Detailed history for patient complains and previous trauma or surgery.
• Physical examination for FHL, AT, any foot and ankle deformities, functional Achilles pathology or ankle range-of-motion deficits.
• VAS score, Achilles tendon Total Rupture Score - ATRS, American Orthopaedic Foot \& Ankle Society (AOFAS) hindfoot score and ankle plantarflexion strength will be assessed preoperatively and at the latest follow-up (minimum of 1 year after the procedure). Research outcome measures: a. Primary (main): Functional outcome of endoscopic versus open FHL transfer in various TA pathology (American Orthopaedic Foot \& Ankle Society (AOFAS) ankle-hindfoot score), Achilles tendon Total Rupture Score - ATRS, ankle plantarflexion strength. .Secondary (subsidiary):
• Wound complication, skin dehiscence and infection rate.
• Expected time to complete return to sports activities or return to previous levels of activity.
• Accelerated rehabilitation.

Conditions

Tendon Tear; Tendinopathy; Achilles Tendon Ruptures; Achilles Injuries Tendon; Achilles Tendon Surgery; Achilles Tendinopathy; Achilles Tendon Repairs/reconstructions; Haglund's Deformity

Keywords

achilles tendon rapture; achilles tendinopathy; achilles tendon transfer; fhl tendon transfer; Flexor hallucis longus tendon transfer; Haglund syndrome; endoscopic FHL transfer

Outcome Measures

Primary Outcomes (1)

• Functional outcome of Ankle joint

  Functional outcome of endoscopic versus open FHL transfer in various TA pathology (American Orthopaedic Foot \& Ankle Society (AOFAS) ankle-hindfoot score), ankle plantarflexion strength.

  one year follow up

Secondary Outcomes (2)

• Complications

  one year follow up

• TIme to return to previous activity

  one year follow up

Study Arms (2)

Group A : open fhl tendon transfer

ACTIVE COMPARATOR

the open surgery group The FHL tendon can be approached through the posterior longitudinal incision The FHL is confirmed by digital retraction of the tendon, watching for flexion of the hallux. Dissection of the FHL tendon is followed to the posterior talus and FHL tunnel, remaining lateral to avoid the neurovascular bundle. Release of the fibro-osseous tunnel along the posterior talus is necessary to gain length. With the hallux and ankle plantar flexed, the FHL tendon is transected as distally as possible. The tendon is fixed to the calcaneus just anterior to the Achilles stump insertion by an interference screw.

Procedure: Open Flexor Hallucis longus transfer to tendon achilles

Group B : endoscopic open fhl tendon transfer

ACTIVE COMPARATOR

• Endoscopic FHL tendon transfer: The endoscopic FHL tendon transfer is usually performed with the scope introduced through the posterolateral portal and instruments through the posteromedial portal. The FHL tendon must be identified during hindfoot working area creation. The FHL tendon is the main hindfoot endoscopic landmark as the neurovascular tibial bundle is located medial to it. First, the calcaneoplasty is completed as described. Next, the FHL tendon is harvested. The posterior fibulo-talocalcaneal ligament complex or Rouvière and Canela ligament is cut as proximal as possible in order to allow free movement of the FHL tendon and allows a straight FHL tendon trajectory to the most posterior aspect of the calcaneal bone. The FHL tendon is pierced with a suture passer, and a lasso loop type suture is tied to provide traction on the tendon. The foot is held in plantar flexion with the hallux flexed, relaxing the flexor hallucis longus (FHL), and the traction suture is grasped an

Procedure: Endoscopic Flexor Hallucis longus tendon transfer to tendon achilles

Interventions

Endoscopic Flexor Hallucis longus tendon transfer to tendon achilles PROCEDURE

The endoscopic FHL tendon transfer is usually performed with the scope introduced through the posterolateral portal and instruments through the posteromedial portal. The FHL tendon must be identified during hindfoot working area creation. First, the calcaneoplasty is completed as described. Next, the FHL tendon is harvested. A tunnel was created into calcenous the tendon is introduced into the tunnel and the tendon is secured with an interference screw of same size than the tunnel

Also known as: Endoscopic FHL tendon transfer to tendon achilles

Group B : endoscopic open fhl tendon transfer

Open Flexor Hallucis longus transfer to tendon achilles PROCEDURE

The FHL tendon can be approached through the posterior longitudinal incision The FHL is confirmed by digital retraction of the tendon, watching for flexion of the hallux. Dissection of the FHL tendon is followed to the posterior talus and FHL tunnel, remaining lateral to avoid the neurovascular bundle. Release of the fibro-osseous tunnel along the posterior talus is necessary to gain length. With the hallux and ankle plantar flexed, the FHL tendon is transected as distally as possible. The tendon is fixed to the calcaneus just anterior to the Achilles stump insertion by an interference screw.

Also known as: Open FHL transfer to tendon achilles

Group A : open fhl tendon transfer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic T.A ruptures more than 6 weeks.
• Non-insertional TA tendinopathy with an injury greater than 50%.
• Haglund deformity plus insertional Achilles tendinopathy (IAT).
• Patients with major degenerative tendon tissues with acute Achilles tendon rupture.
• Acute Achilles tendon rupture in athletic patients.
• Failed conservative or operatively treated ruptures healed T.A with both reduced function and significantly lengthening of the Achilles tendon after focused physiotherapy (treatment has failed to restore function to a level evaluated as satisfactory by the patients).

You may not qualify if:

• h. Malalignment, or end-stage tibiotalar and subtalar joint osteoarthritis. i. The presence of FHL tendon pathology. j. Acute or chronic infection. k. Sever bone loss or defects. Systemic immunodeficiency or chemotherapy

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital , orthopaedic and trauma surgery department arthroscopic unit

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (7)

• Attia AK, Mahmoud K, d'Hooghe P, Bariteau J, Labib SA, Myerson MS. Outcomes and Complications of Open Versus Minimally Invasive Repair of Acute Achilles Tendon Ruptures: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Am J Sports Med. 2023 Mar;51(3):825-836. doi: 10.1177/03635465211053619. Epub 2021 Dec 15.

  PMID: 34908499 BACKGROUND

• Alhaug OK, Berdal G, Husebye EE, Hvaal K. Flexor hallucis longus tendon transfer for chronic Achilles tendon rupture. A retrospective study. Foot Ankle Surg. 2019 Oct;25(5):630-635. doi: 10.1016/j.fas.2018.07.002. Epub 2018 Jul 18.

  PMID: 30321934 BACKGROUND

• Wegrzyn J, Luciani JF, Philippot R, Brunet-Guedj E, Moyen B, Besse JL. Chronic Achilles tendon rupture reconstruction using a modified flexor hallucis longus transfer. Int Orthop. 2010 Dec;34(8):1187-92. doi: 10.1007/s00264-009-0859-1. Epub 2009 Aug 21.

  PMID: 19697026 BACKGROUND

• Goncalves S, Caetano R, Corte-Real N. Salvage Flexor Hallucis Longus Transfer for a Failed Achilles Repair: Endoscopic Technique. Arthrosc Tech. 2015 Sep 7;4(5):e411-6. doi: 10.1016/j.eats.2015.03.017. eCollection 2015 Oct.

  PMID: 26697296 BACKGROUND

• Hahn F, Meyer P, Maiwald C, Zanetti M, Vienne P. Treatment of chronic achilles tendinopathy and ruptures with flexor hallucis tendon transfer: clinical outcome and MRI findings. Foot Ankle Int. 2008 Aug;29(8):794-802. doi: 10.3113/FAI.2008.0794.

  PMID: 18752777 BACKGROUND

• DeCarbo WT, Hyer CF. Interference screw fixation for flexor hallucis longus tendon transfer for chronic Achilles tendonopathy. J Foot Ankle Surg. 2008 Jan-Feb;47(1):69-72. doi: 10.1053/j.jfas.2007.09.001. Epub 2007 Nov 26.

  PMID: 18156070 BACKGROUND

• Lee KB, Park YH, Yoon TR, Chung JY. Reconstruction of neglected Achilles tendon rupture using the flexor hallucis tendon. Knee Surg Sports Traumatol Arthrosc. 2009 Mar;17(3):316-20. doi: 10.1007/s00167-008-0693-9. Epub 2008 Dec 16.

  PMID: 19083203 BACKGROUND

Related Links

• Endoscopic Flexor Hallucis Longus Transfer for Chronic Noninsertional Achilles Tendon Rupture
• Flexor hallucis longus tendon transfer for chronic Achilles tendon rupture. A retrospective study

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: anesthesia ,
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisstant lecturer

Model Details: •This is a Prospective, randomized control trial. The study will be conducted on 30 patients complaining of chronic Achilles tendon rupture, Achilles insertional tendinopathy, Haglund syndrome planned for FHL transfer in Assiut university hospital. Patients will be randomized to two groups one group endoscopic FHL will be conducted in other hand second group open FHL will be conducted.

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: April 4, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)