Endoscopic Flexor Hallucis Longus Transfer vs Minimally Invasive Repair in Acute Achilles Tendon Rupture

Achilles Tendon Rupture Clinical Trial

Official title:

Outcomes Evaluation of Endoscopic Flexor Hallucis Longus Transfer Versus Minimally Invasive Primary Repair in Patients With Acute Achilles Tendon Rupture

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06114368
• Other study ID #: 26543
• Status: Enrolling by invitation
• Start date: March 5, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: November 2023
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Achilles Tendon Injury
• Achilles Tendon Rupture
• Achilles Tendon Surgery
• Rupture
• Tendon Injuries

Intervention

Procedure:
• Surgery for the treatment of Acute Achilles tendon rupture
Two different surgical techniques were applied in two different patient groups for the same disease. Their outcomes are evaluated and compared

Locations

Country	Name	City	State
Greece	General Hospital of Naoussa	Náousa	Central Macedonia

Sponsors (3)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	General Hospital of Naoussa, Private Orthopedics Practice P. Symeonidis

Country where clinical trial is conducted

Greece, 

References & Publications (4)

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. — View 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 — View 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. 202 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction assessed with the Achilles Tendon Total Rupture Score	Evaluated and quantified with the Achilles Tendon Total Rupture Score (minimum value = 0 - worst outcome, maximal value = 100 - best outcome)	More than 12 months postoperatively
Secondary	Complication Rate	Complications will be recorded and categorized: Rerupture, Infection, Nerve injury, Miscellaneous	More than 12 months postoperatively
Secondary	Calf Circumference	Calf circumference measured 15 cm distally to the inferior pole of the patella. Contralateral limb calf circumference will also be measured. The Calf Circumference Difference will be calculated and compared between the two groups.	More than 12 months postoperatively
Secondary	Ankle Circumference	Ankle circumference measured 8 cm proximally to the lateral malleolus. Contralateral limb ankle circumference will also be measured. The Ankle Circumference Difference will be calculated and compared between the two groups.	More than 12 months postoperatively
Secondary	Ankle joint Range of Motion	Active and Passive Ankle joint Range of Motion will be calculated with an electronic goniometer. Contralateral limb Range of Ankle joint Motion will also be measured. The Range of Motion Difference will be calculated and compared between the two groups.	More than 12 months postoperatively