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

NCT07312097 — Not applicable, Completed, 40 participants, Haseki Training and Research Hospital

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

RegistryNCT07312097
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment40 (Actual)
SponsorHaseki Training and Research Hospital (Other)
ConditionsAcute Achilles Tendon Rupture
InterventionsConservative treatment, Surgical Repair (Other, procedure)
Datesstart 2023-08-20, primary completion 2024-02-20, completion 2024-12-20, first posted 2025-12-31, last updated 2025-12-31
Locations1 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

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Conservative TreatmentActive comparatorOther: Conservative treatmentParticipants 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 RepairActive comparatorProcedure: Surgical RepairOpen 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.
  • 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.

+Outcome measures

Primary outcomes

  • Peak Plantar Flexion Torque [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.
  • Total Work During Plantar Flexion [12-18 months post-injury]: Total work during plantar flexion (Joules) measured using an isokinetic dynamometer (HUMAC NORM 2015) at a standardized angular velocity.
  • Initial Plantar Flexion Torque [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

  • Achilles Tendon Resting Angle (ATRA) [12-18 months post-injury]: Achilles tendon resting angle (degrees) measured using a standardized clinical goniometric method.
  • Pain Intensity (VAS) [12-18 months post-injury]: Pain intensity measured using the Visual Analog Scale (VAS), reported on a 0-10 scale
  • Leppilahti Achilles tendon rupture score [12-18 months post-injury]: Leppilahti Achilles tendon rupture score (points) measured using the standardized Leppilahti scoring system.
  • American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score [12-18 months post-injury]: American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score (points) measured using the standardized AOFAS scoring system
  • Foot and Ankle Disability Index (FADI) [12-18 months post-injury]: Foot and ankle function measured using the Foot and Ankle Disability Index (FADI), reported as a numerical score (points)
  • Rerupture Rate [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.

+Eligibility

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)

+Locations (1)

FacilityCityCountryStatus
Haseki Training and Research HospitalIstanbul, Haseki Training and Research HospitalTurkey (Türkiye)