Could Conservative Treatment Become the New Gold Standard in the Treatment of Acute Achilles Tendon Ruptures: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Peak Plantar Flexion Torque
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Peak Plantar Flexion Torque
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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)
- Rerupture Rate(12-18 months post-injury)