Clinical trial NCT06114368: Endoscopic Flexor Hallucis Longus Transfer vs Minimally Invasive Repair in Acute Achilles Tendon Rupture
Official title: Outcomes Evaluation of Endoscopic Flexor Hallucis Longus Transfer Versus Minimally Invasive Primary Repair in Patients With Acute Achilles Tendon Rupture
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Achilles Tendon Rupture
Achilles Tendon Surgery
Achilles Tendon Injury
Keywords: Achilles tendon
rupture
Endoscopic
Flexor Hallucis Longus transfer
repair
Percutaneous Achilles Repair System - PARS
Minimally invasive
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: General Hospital of Naoussa
name: Private Orthopedics Practice P. Symeonidis
First posted: 2023-11-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Achilles tendon rupture operated exclusively with these two surgical techniques, by these two particular surgeons (A.E. and P.S.) in their respective hospitals (General Hospital of Naoussa, St Luke's Hospital).

Brief summary: The goal of this observational study is to compare the outcomes of two different surgical techniques (Endoscopic Flexor Hallucis Longus transfer - Group 1 vs Minimally Invasive primary repair - Group 2) for patients with acute Achilles tendon rupture. The main questions to be answered are:

1. Which group's patients are more satisfied?
2. Which group's patients appear to have a greater complication rate?
3. Which group's patients have greater calf and ankle circumference compared to the unaffected limb?
4. Which group's patients have greater passive and active range of ankle motion compared to the unaffected limb?
5. Are group 1 patients characterized by strength deficit in hallux flexion power?

Detailed description: Two separate foot and ankle surgeons in Northern Greece prefer to use a different surgical technique in their respective patients with Acute Achilles tendon rupture.

The first one (A.E.) prefers to perform only Endoscopic Flexor Hallucis Longus transfer, while the second one (P.S.) prefers to perform only Minimally invasive primary repair assisted by the Achillon device (Percutaneous Achilles Repair System - PARS). They both agreed to enroll their recently operated patients (last 5 years) in this retrospective study, which will be conducted by the researcher (M.K.). The patient's study may be retrospective, nevertheless, the patients were randomly chosen and enrolled by a prospectively designed study protocol. Each surgeon applied the respective surgical treatment modality regardless of each patient's characteristics, biometrics, or comorbidities. Inclusion and Elimination criteria will be applied. The patient's satisfaction will be evaluated with the Achilles Tendon Total Rupture Score (ATRS). Complications will be documented. Calf and ankle circumference will be measured and compared to the contralateral healthy limb. Ankle passive and active range of motion will be measured and compared to the contralateral healthy limb. Possible correlations will be investigated regarding patient age, BMI, history of smoking, level of activity, and comorbidities.

Eligibility criteria: Inclusion Criteria:

* Signed Consent Form
* Age between 18-75 years
* Acute Achilles Tendon Rupture (\<3 weeks)
* Surgical Management with Endoscopic Flexor Hallucis Longus transfer or Minimally Invasive primary tendon repair
* More than 12 months postoperative follow-up
* Patients operated after 2015

Exclusion Criteria:

* Inability or Unwillingness to cooperate
* Medically unfit for examination (e.g. due to terminal illness)
* Age less than 18 or more than 75 years
* Non-operative Management as definitive treatment
* Surgical Management other than the ones described in the inclusion criteria
* Neglected Achilles Tendon Rupture (\>3 weeks)
* Bilateral Achilles Tendon Rupture
* Patients operated before 2015
* Comorbidities interfering with the secondary outcomes (e.g. Venous insufficiency resulting in lower limb excessive edema interferes with ankle and calf circumference, rheumatoid arthritis and/or previous foot and ankle surgery interferes with active and passive range of motion of the ankle, etc)

Primary outcomes:
measure: Patient Satisfaction assessed with the Achilles Tendon Total Rupture Score
timeFrame: More than 12 months postoperatively
Secondary outcomes:
measure: Complication Rate
timeFrame: More than 12 months postoperatively
measure: Calf Circumference
timeFrame: More than 12 months postoperatively
measure: Ankle Circumference
timeFrame: More than 12 months postoperatively
measure: Ankle joint Range of Motion
timeFrame: More than 12 months postoperatively
Other outcomes:
Locations:
city: Náousa
country: Greece
facility: General Hospital of Naoussa
state: Central Macedonia
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Michail K. Kotsapas, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdelatif NMN, Batista JP. Outcomes of Percutaneous Achilles Repair Compared With Endoscopic Flexor Hallucis Longus Tendon Transfer to Treat Achilles Tendon Ruptures. Foot Ankle Int. 2022 Sep;43(9):1174-1184. doi: 10.1177/10711007221096674. Epub 2022 Jun 10.
citation: Abdelatif NMN, Batista JP. Endoscopic Flexor Hallucis Longus Transfer for the Management of Acute Achilles Tendon Ruptures in Professional Soccer Players. Foot Ankle Int. 2022 Feb;43(2):164-175. doi: 10.1177/10711007211036439. Epub 2021 Sep 24.
citation: Batista JP, Abdelatif NMN, Del Vecchio JJ, Diniz P, Pereira H. Endoscopic Flexor Hallucis Longus Transfer for the Management of Acute Achilles Tendon Ruptures: A Prospective Case Series Report With a Minimum of 18 Months' Follow-Up. J Foot Ankle Surg. 2020 Sep-Oct;59(5):927-937. doi: 10.1053/j.jfas.2019.12.008. Epub 2020 Jun 9.
citation: Martin KD, Crouser NJ, Khan IA. Minimally Invasive Mid-Substance Achilles Tendon Repair Using the Percutaneous Achilles Repair System (PARS). JBJS Essent Surg Tech. 2022 Sep 22;12(3):e21.00050. doi: 10.2106/JBJS.ST.21.00050. eCollection 2022 Jul-Sep.