An observational study in Achilles Tendon Rupture, Achilles Tendon Surgery and Achilles Tendon Injury, sponsored by Aristotle University Of Thessaloniki. Enrolling by invitation at 1 site in Greece. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Aristotle University Of Thessaloniki · Observational
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:
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.
78 studies on the registry are indexed under Rupture; 17 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 31 observational studies indexed under Rupture.
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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).
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Exclusion Criteria:
Patients with acute Achilles tendon rupture managed with Endoscopic Flexor Hallucis Longus transfer by one surgeon (A.E.) in one hospital (General Hospital of Naoussa, Naoussa, Greece), all of which followed the same rehabilitation protocol.
Procedure: Surgery for the treatment of Acute Achilles tendon rupture
Patients with acute Achilles tendon rupture managed with Minimally Invasive Primary repair by one surgeon (P.S.) in one hospital (St. Luke's Hospital, Thessaloniki, Greece), all of which followed the same rehabilitation protocol.
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
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)
Time frame: More than 12 months postoperatively
Complication Rate
Complications will be recorded and categorized: Rerupture, Infection, Nerve injury, Miscellaneous
Time frame: More than 12 months postoperatively
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.
Time frame: More than 12 months postoperatively
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.
Time frame: More than 12 months postoperatively
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.
Time frame: More than 12 months postoperatively
Plan to share: Undecided — The records of each patient to be enrolled belong to the respective surgeon (A.E. and P.S.). Thus, the records of each patient will be entrusted to the main researcher (M.K.) with the obligation to maintain doctor-patient confidentiality. The final study results will not reveal any sensitive patient data (de-identification). Photos and videos of each patient's examination may be taken after ensuring their written and oral informed consent.
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