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Completed

NCT Number: NCT07312097

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

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.

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Key information

Conditions

Acute Achilles Tendon Rupture

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haseki Training and Research Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Peak Plantar Flexion Torque

    Time frame: 12-18 months post-injury

    Peak plantar flexion torque (Newton-meters, Nm) measured using an isokinetic dynamometer (HUMAC NORM 2015) at a standardized angular velocity.

  2. Total Work During Plantar Flexion

    Time frame: 12-18 months post-injury

    Total work during plantar flexion (Joules) measured using an isokinetic dynamometer (HUMAC NORM 2015) at a standardized angular velocity.

  3. Initial Plantar Flexion Torque

    Time frame: 12-18 months post-injury

    Initial plantar flexion torque (Newton-meters, Nm) measured using an isokinetic dynamometer (HUMAC NORM 2015) at a standardized angular velocity

Secondary outcomes

  1. Achilles Tendon Resting Angle (ATRA)

    Time frame: 12-18 months post-injury

    Achilles tendon resting angle (degrees) measured using a standardized clinical goniometric method.

  2. Pain Intensity (VAS)

    Time frame: 12-18 months post-injury

    Pain intensity measured using the Visual Analog Scale (VAS), reported on a 0-10 scale

  3. Leppilahti Achilles tendon rupture score

    Time frame: 12-18 months post-injury

    Leppilahti Achilles tendon rupture score (points) measured using the standardized Leppilahti scoring system.

  4. American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score

    Time frame: 12-18 months post-injury

    American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score (points) measured using the standardized AOFAS scoring system

  5. Foot and Ankle Disability Index (FADI)

    Time frame: 12-18 months post-injury

    Foot and ankle function measured using the Foot and Ankle Disability Index (FADI), reported as a numerical score (points)

  6. Rerupture Rate

    Time frame: 12-18 months post-injury

    Achilles tendon rerupture determined by clinical examination and/or imaging confirmation and recorded as the number of participants experiencing rerupture.

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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