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

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.

Study Overview

• Status: Completed
• Conditions: Acute Achilles Tendon Rupture
• Intervention / Treatment: Other: Conservative treatment; Procedure: Surgical Repair

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Haseki Training and Research Hospital
    • Istanbul, Haseki Training and Research Hospital, Turkey (Türkiye), 34265
      • Haseki Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plantar Flexion Torque	Peak plantar flexion torque (Newton-meters, Nm) measured using an isokinetic dynamometer (HUMAC NORM 2015) at a standardized angular velocity.	12-18 months post-injury
Total Work During Plantar Flexion	Total work during plantar flexion (Joules) measured using an isokinetic dynamometer (HUMAC NORM 2015) at a standardized angular velocity.	12-18 months post-injury
Initial Plantar Flexion Torque	Initial plantar flexion torque (Newton-meters, Nm) measured using an isokinetic dynamometer (HUMAC NORM 2015) at a standardized angular velocity	12-18 months post-injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achilles Tendon Resting Angle (ATRA)	Achilles tendon resting angle (degrees) measured using a standardized clinical goniometric method.	12-18 months post-injury
Pain Intensity (VAS)	Pain intensity measured using the Visual Analog Scale (VAS), reported on a 0-10 scale	12-18 months post-injury
Leppilahti Achilles tendon rupture score	Leppilahti Achilles tendon rupture score (points) measured using the standardized Leppilahti scoring system.	12-18 months post-injury
American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score	American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score (points) measured using the standardized AOFAS scoring system	12-18 months post-injury
Foot and Ankle Disability Index (FADI)	Foot and ankle function measured using the Foot and Ankle Disability Index (FADI), reported as a numerical score (points)	12-18 months post-injury
Rerupture Rate	Achilles tendon rerupture determined by clinical examination and/or imaging confirmation and recorded as the number of participants experiencing rerupture.	12-18 months post-injury

Collaborators and Investigators

• Sponsor: Haseki Training and Research Hospital

Publications and helpful links

Helpful Links

• Official website of Haseki Training and Research Hospital, where the study on conservative versus operative treatment of acute Achilles tendon rupture was conducted. Provides hospital information and contact details for study-related queries.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2023
• Primary Completion (Actual): February 20, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: conservative treatment; Functional rehabilitation; Isokinetic strength; achilles tendon rupture
• Additional Relevant MeSH Terms: Therapeutics; Biological Phenomena; Regeneration; Conservative Treatment; Wound Healing
• Other Study ID Numbers: 113-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared. The decision is based on patient confidentiality, ethical considerations, and the study's informed consent process, which did not include provisions for data sharing with external researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No