Could Conservative Treatment Become the New Gold Standard in the Treatment of Acute Achilles Tendon Ruptures: A Prospective Randomized Controlled Trial
| Registry | NCT07312097 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 40 (Actual) |
| Sponsor | Haseki Training and Research Hospital (Other) |
| Conditions | Acute Achilles Tendon Rupture |
| Interventions | Conservative treatment, Surgical Repair (Other, procedure) |
| Dates | start 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 in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Acute Achilles Tendon Rupture All trials of Conservative treatment All trials of Surgical Repair
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Conservative Treatment | Active comparator | Other: Conservative treatment | Participants follow the GAPNOT functional rehabilitation protocol, including initial immobilization in plantar flexion, gradual partial to full weight-bearing, and supervised physiotherapy to improve plantar flexion strength and ankle range of motion. |
| Surgical Repair | Active comparator | Procedure: Surgical Repair | Open end-to-end Achilles tendon repair using the locked Krackow suture technique, followed by epitendinous augmentation and standardized early functional rehabilitation including gradual weight-bearing and physiotherapy. |
Sex: All, ages: 18 Years to 50 Years
Inclusion Criteria: * Adults aged 18-50 years * Acute complete Achilles tendon rupture (tendon-to-tendon) * Injury occurred within 3 weeks prior to presentation * Willingness and ability to comply with the functional rehabilitation program Exclusion Criteria: * Injury occurred more than 3 weeks prior to presentation * Open Achilles tendon rupture * History of preexisting foot or ankle pathology * Musculotendinous, insertional, or calcaneal avulsion-type Achilles tendon injuries * Presence of additional risk factors increasing Achilles tendon injury risk (e.g., diabetes mellitus, immunosuppressive therapy, fluoroquinolone use, or systemic corticosteroid use)
| Facility | City | Country | Status |
|---|---|---|---|
| Haseki Training and Research Hospital | Istanbul, Haseki Training and Research Hospital | Turkey (Türkiye) |