CUHK Achilles Tendon Disorder Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Victorian Institute of Sports Assessment (VISA-A)
研究概览
简要总结
This is a long-term research registry for patients with Achilles tendon disorders (like tears, chronic pain, or ruptures) as well as healthy adults without tendon problems. The goal is to collect detailed information over time to understand which treatments work best for different people, identify risk factors for injury, and improve overall care. Adults over 18, both with and without Achilles tendon conditions, are eligible to join. Participants will attend several assessment visits at the Prince of Wales Hospital over the first year (at the start, 6 weeks, 3, 4, 6, and 12 months) for physical tests, ultrasounds, and questionnaires. After the first year, follow-up continues with annual online questionnaires for up to five years. The main measure is a standard questionnaire about tendon pain and function (VISA-A). The study aims to use this information to guide better, more personalized rehabilitation strategies, improve patient outcomes, and reduce long-term disability. All participation is voluntary and requires written consent.
详细描述
This is a prospective, longitudinal Achilles Tendon Registry study. The registry is conceived as a foundational cohort study designed to systematically address critical evidence gaps in the management of Achilles tendon pathologies. The Achilles tendon, while robust, is susceptible to a spectrum of disorders including acute ruptures and chronic tendinopathies, often summarized colloquially as the "Achilles heel." Current clinical management strategies for these conditions are characterized by heterogeneity, largely due to a paucity of high-quality, longitudinal comparative effectiveness data. This registry aims to mitigate this gap by creating a centralized repository of standardized, prospective data, thereby enabling rigorous evaluation of treatment outcomes, prognostic factors, and long-term sequelae.
The primary objective is to establish a comprehensive, prospectively enrolled cohort of individuals with Achilles tendon disorders, complemented by a cohort of asymptomatic controls, to facilitate comparative and predictive analyses. The study is explicitly designed to answer three pivotal research questions. First, it will investigate the prognostic influence of baseline structural and vascular status of the tendon, as quantified by ultrasonographic and elastographic metrics, on functional recovery. Second, it will assess whether a pre-existing diagnosis of Achilles tendinopathy constitutes a significant risk factor for subsequent acute tendon rupture. Third, it will analyze differential treatment responsiveness, aiming to identify which patient subgroups, defined by specific baseline characteristics, demonstrate optimal outcomes with specific treatment modalities.
The study methodology is that of a prospective, single-center cohort study to be conducted at the Prince of Wales Hospital in Hong Kong. The target sample size is a minimum of 500 participants, to be consecutively enrolled from 2025 to 2028. The participant pool will include adults over the age of 18 with a diagnosis of an Achilles tendon disorder, as well as asymptomatic control participants without tendon pathology. Key exclusion criteria encompass any comorbid physical or psychological condition that would impair the ability to complete study assessments or provide informed consent, and concomitant diseases that severely affect lower limb function (e.g., severe osteoarthritis, prior amputation, active inflammatory arthritis, or paralysis).
The follow-up protocol is structured into intensive initial and long-term phases. All participants will undergo comprehensive in-person assessments at baseline, 6 weeks, 3 months, 6 months, and 1 year post-enrollment. These assessments constitute the core data collection points and encompass a multi-modal battery of outcome measures. Following the initial 1-year follow-up, the protocol transitions to long-term monitoring, wherein all self-reported outcome measures will be collected annually via online questionnaires at years 2, 3, 4, and 5.
The primary outcome measure is the Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire, a validated, disease-specific patient-reported outcome tool scored from 0 to 100. A comprehensive suite of secondary outcome measures will be collected to provide a holistic assessment. These include patient-reported outcomes such as the Numeric Pain Rating Scale (NPRS) and the Foot and Ankle Outcome Score (FAOS). Functional and physical performance measures are integral and consist of the Achilles Tendon Resting Angle (ATRA), calf muscle strength quantified via hand-held dynamometry, the heel raise endurance test, and a one-legged counter-movement jump test performed on a pressure mat. Biomechanical analysis includes foot pressure distribution assessment and treadmill-based gait analysis using a Zebris system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (>18 years of age)
排除标准
- •Any physical or psychological comorbidity that would impair the ability to complete study assessments (e.g., significant neurological deficits) or preclude the provision of informed consent.
- •Concomitant diseases that severely affect lower limb function or assessment (e.g., severe osteoarthritis of the knee or hip, prior lower limb amputation, peripheral vascular disease, active rheumatoid arthritis, lower limb paralysis, etc.)
研究组 & 干预措施
Healthy group
Healthy individuals without any Achilles tendon injury
Achilles tendon disorder group
Individuals with any Achilles tendon disorder
结局指标
主要结局
Victorian Institute of Sports Assessment (VISA-A)
时间窗: From enrollment to 5 years after baseline assessment
The primary outcome measure will be the Victorian Institute of Sport Assessment (VISA-A) questionnaire, available in either the original English or validated Chinese version, depending on the participant's native language. This specific scoring system developed for the Achilles tendon is the most widely used score for clinical Achilles research. The VISA-A is scored on a scale of 0 to 100; lower scores indicate more severity of symptoms, while a score of 100 indicates a healthy and pain-free Achilles tendon.
次要结局
- Numeric Pain Rating Scale (NPRS)(From enrollment to 5 years after baseline assessment)
- Foot and Ankle Outcome Scores (FAOS)(From enrollment to 5 years after baseline assessment)
- Achilles tendon resting angle (ATRA)(From enrollment to 1 year after baseline assessment)
- Royal London hospital test(From enrollment to 1 year after baseline assessment)
- Calf Muscle Strength(From enrollment to 1 year after baseline assessment)
- Heel raise test(From enrollment to 1 year after baseline assessment)
- Jump test(From enrollment to 1 year after baseline assessment)
- Foot pressure distribution(From enrollment to 1 year after baseline assessment)
- Zebris Treadmill Gait and Stance Analysis(From enrollment to 1 year after baseline assessment)
- Tendon oxygenation and vascularity(From enrollment to 1 year after baseline assessment)
- Achilles Ultrasonography- Tendon Thickness(From enrollment to 1 year after baseline assessment)
- Achilles Ultrasonography - Tendon vascularity(From enrollment to 1 year after baseline assessment)
- Achilles Ultrasonography - Tendon elasticity(From enrollment to 1 year after baseline assessment)
- Thermographic tendon temperature(From enrollment to 1 year after baseline assessment)
研究者
Samuel KK Ling
Clinical Assistant Professor of Orthopaedics and Traumatology, CUHK Head of the Foot and Ankle Team / Honorary Associate Consultant, Prince of Wales Hospital Specialist in Orthopaedics and Traumatology, CUHK Medical Centre
Chinese University of Hong Kong
