Assiut university hospital , orthopaedic and trauma surgery department arthroscopic unit
Asyut, Asyut Governorate, 71515, Egypt
NCT Number: NCT06639308
* 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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Asyut, Asyut Governorate, 71515, Egypt
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.
b. 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 c. Sample Size Calculation:
Sample size:
Based on determining the main outcome variable, the estimated minimum required sample size is 24 patients (12 patient in each group)(4)
The sample was calculated using G*power software 3.1.9.2., based on the following assumptions:
Main outcome variable is the difference between mean value of strength of planter flexion of ankle joint using the American ankle and foot functional score (AOFAS).
Based on clinical experience we expected to find large effect size difference (4)between 2 groups Main statistical test is independent t-test to detect the difference between the 2 groups.
Alpha = 0.05 Power = 0.80 Effect size = 1.2
Preoperative assessment:
A- Detailed history and examination:
B- Radiological assessment
C- Surgical procedure
A-Endoscopic FHL tendon transfer:
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 and gently pulled, allowing for as distal a tenotomy as possible. Tenotomy is performed with arthroscopic scissors while the foot is maintained in the aforementioned position(9) (12).
B- Open FHL transfer:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Endoscopic FHL tendon transfer to tendon achilles
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.
Other names: Open FHL transfer to tendon achilles
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.
Time frame: one year follow up
Wound complication( skin dehiscence and infection rate)
Time frame: one year follow up
Expected time to complete return to sports activities or return to previous levels of activity.
Assiut University
Other
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