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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07312097
Enrollment
40
Registered
2025-12-31
Start date
2023-08-20
Completion date
2024-12-20
Last updated
2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Achilles Tendon Rupture

Keywords

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

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.

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.

Interventions

OTHERConservative 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.

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.

Sponsors

Haseki Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Peak Plantar Flexion Torque12-18 months post-injuryPeak plantar flexion torque (Newton-meters, Nm) measured using an isokinetic dynamometer (HUMAC NORM 2015) at a standardized angular velocity.
Total Work During Plantar Flexion12-18 months post-injuryTotal work during plantar flexion (Joules) measured using an isokinetic dynamometer (HUMAC NORM 2015) at a standardized angular velocity.
Initial Plantar Flexion Torque12-18 months post-injuryInitial plantar flexion torque (Newton-meters, Nm) measured using an isokinetic dynamometer (HUMAC NORM 2015) at a standardized angular velocity

Secondary

MeasureTime frameDescription
American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score12-18 months post-injuryAmerican Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score (points) measured using the standardized AOFAS scoring system
Achilles Tendon Resting Angle (ATRA)12-18 months post-injuryAchilles tendon resting angle (degrees) measured using a standardized clinical goniometric method.
Rerupture Rate12-18 months post-injuryAchilles tendon rerupture determined by clinical examination and/or imaging confirmation and recorded as the number of participants experiencing rerupture.
Foot and Ankle Disability Index (FADI)12-18 months post-injuryFoot and ankle function measured using the Foot and Ankle Disability Index (FADI), reported as a numerical score (points)
Pain Intensity (VAS)12-18 months post-injuryPain intensity measured using the Visual Analog Scale (VAS), reported on a 0-10 scale
Leppilahti Achilles tendon rupture score12-18 months post-injuryLeppilahti Achilles tendon rupture score (points) measured using the standardized Leppilahti scoring system.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026