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

NCT07312097 | Completed

• 1 other identifier: 113-2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Achilles Tendon Rupture

Keywords

achilles tendon rupture; Isokinetic strength; Functional rehabilitation; conservative treatment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Achilles Tendon Resting Angle (ATRA)

  12-18 months post-injury

• Pain Intensity (VAS)

  12-18 months post-injury

• Leppilahti Achilles tendon rupture score

  12-18 months post-injury

• American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score

  12-18 months post-injury

• Foot and Ankle Disability Index (FADI)

  12-18 months post-injury

Study Arms (2)

Conservative Treatment

ACTIVE COMPARATOR

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

Surgical Repair

ACTIVE COMPARATOR

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

Interventions

Conservative treatment OTHER

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.

Conservative Treatment

Surgical Repair PROCEDURE

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.

Surgical Repair

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

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

Location

Related 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.

MeSH Terms

Interventions

Conservative Treatment; Wound Healing

Intervention Hierarchy (Ancestors)

Therapeutics; Regeneration; Biological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No parties were masked in this trial. Both participants and investigators were aware of the assigned treatment group throughout the study. Outcome assessments were performed openly, without blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were allocated in a 1:1 ratio to either the conservative treatment group or the surgical repair group using a parallel assignment model. Both groups received standardized early functional rehabilitation protocols specific to their treatment type, and outcomes were compared after a minimum 12-month follow-up.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 31, 2025
• Study Start: August 20, 2023
• Primary Completion: February 20, 2024
• Study Completion: December 20, 2024
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)