NCT07312097

Could Conservative Treatment Become the New Gold Standard in Achilles Tendon Ruptures?

Could Conservative Treatment Become the New Gold Standard in the Treatment of Acute Achilles Tendon Ruptures: A Prospective Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Haseki Training and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare conservative and surgical treatments for acute Achilles tendon rupture. Forty-four patients were randomly assigned to either a conservative rehabilitation protocol or open surgical repair. Functional outcomes were evaluated using isokinetic muscle strength testing and clinical scoring systems such as the ATRS, AOFAS, FADI, VAS, and Leppilahti scores. The results showed no significant difference between the two groups in terms of strength, tendon length, or clinical outcomes. Rerupture rates were similar, while wound complications occurred only in the surgical group. The findings suggest that conservative treatment combined with early functional rehabilitation can provide outcomes comparable to surgery, with fewer complications. Conservative treatment may be a safe and effective alternative for managing acute Achilles tendon ruptures.

Detailed description

Achilles tendon rupture is a common sports-related injury, and the optimal treatment approach remains controversial. Surgical repair has traditionally been considered the gold standard due to lower rerupture rates and better restoration of tendon continuity. However, surgery carries risks such as wound infection, nerve injury, and postoperative complications. Recent advances in rehabilitation techniques have led to renewed interest in conservative management, which allows for early mobilization and functional recovery without surgical risks. This study was designed as a prospective, randomized clinical trial to objectively compare conservative and surgical treatments for acute Achilles tendon rupture. Forty-four patients were randomly allocated to either a conservative treatment protocol based on the GAPNOT early functional rehabilitation model or open surgical repair using the Krackow suture technique. Functional recovery was assessed using isokinetic muscle testing for plantar flexion and dorsiflexion strength, as well as validated clinical scoring systems (ATRS, AOFAS, FADI, VAS, and Leppilahti). The primary objective of this study is to determine whether conservative treatment can achieve comparable functional and biomechanical outcomes to surgical repair while minimizing complications. The results are expected to contribute to establishing evidence-based treatment guidelines and may support conservative management as a new gold standard in selected patient populations.

Conditions

• Acute Achilles Tendon Rupture

Interventions

Type	Name	Description
OTHER	Conservative treatment	Participants follow the GAPNOT functional rehabilitation protocol. Initially immobilized in maximum plantar flexion with non-weight-bearing. At 2 weeks partial weight-bearing is allowed with an Achilles boot and heel lifts; by weeks 4-6 weight-bearing is increased and supervised physiotherapy is initiated focusing on plantar flexion strength, calf strengthening and ankle range of motion. Outcomes assessed at 12-18 months by isokinetic testing and clinical scores.
PROCEDURE	Surgical Repair	Participants undergo open end-to-end Achilles tendon repair using the locked Krackow suture technique with 2-0 FiberWire and epitendinous augmentation. Postoperatively, standardized early functional rehabilitation is applied including gradual weight-bearing, ankle mobilization and physiotherapy focused on plantar flexion strength and ROM. Outcomes assessed at 12-18 months by isokinetic testing and clinical scores.

Timeline

• Start date: 2023-08-20
• Primary completion: 2024-02-20
• Completion: 2024-12-20
• First posted: 2025-12-31
• Last updated: 2025-12-31

Locations

1 site across 1 country: Turkey (Türkiye)