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

NCT ID: NCT07312097

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-20

Study Completion Date

2024-12-20

Brief Summary

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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

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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

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Acute Achilles Tendon Rupture

Keywords

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achilles tendon rupture Isokinetic strength Functional rehabilitation conservative treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Conservative treatment

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Surgical Repair

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haseki Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Haseki Training and Research Hospital

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

Site Status

Countries

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Turkey (Türkiye)

Related Links

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https://hasekieah.saglik.gov.tr

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.

Other Identifiers

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113-2023

Identifier Type: -

Identifier Source: org_study_id