Eendoscopic Versus Open Flexor Hallucis Longus Transfer in Managing Various Tendon Achilles Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Assiut University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Functional outcome of Ankle joint
Study Overview
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.
Detailed Description
It is research that will be applied on patients with tendon Achilles disorders and planned for a Flexor hallucis longus (FHL) tendon transfer to augment and strength planter flexion power of ankle. Using endoscopic techniques provided the advantage of managing pathology with a low risk of soft-tissue complications and improve outcome.
The study will be approved from Ethical and research committee of the faculty of medicine Asyut University.
Type of the study: This is a Prospective, randomized control trial.
- Study Setting: Department of Orthopaedic and trauma surgery, Assiut university.
- Study subjects:
- Inclusion criteria:
- 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
anesthesia ,
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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).
Exclusion Criteria
- •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
Arms & Interventions
Group A : open fhl tendon transfer
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.
Intervention: Open Flexor Hallucis longus transfer to tendon achilles (Procedure)
Group B : endoscopic open fhl tendon transfer
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. Next, the FHL tendon is harvested. The posterior fibulo-talocalcaneal ligament complex 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 and finally fixation of FHL by Bio-absorbable screw.
Intervention: Endoscopic Flexor Hallucis longus tendon transfer to tendon achilles (Procedure)
Outcomes
Primary Outcomes
Functional outcome of Ankle joint
Time Frame: one year follow up
Functional outcome of endoscopic versus open FHL transfer in various TA pathology (American Orthopaedic Foot \& Ankle Society (AOFAS) ankle-hindfoot score), ankle plantarflexion strength.
Secondary Outcomes
- Complications(one year follow up)
- TIme to return to previous activity(one year follow up)
Investigators
Khaled Mohsen Mohammed Ahmed
Asisstant lecturer
Assiut University