Clinical and Functional Evaluation of Orthobiological Therapies in Musculoskeletal Conditions
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Pain scale
研究概览
简要总结
To evaluate the clinical and functional effects of using orthobiological therapies (hyaluronic acid, platelet-rich plasma, bone marrow aspirate, nanofat, among others) in the treatment of various musculoskeletal diseases in patients routinely treated at the Proregen Medical Clinic and its affiliates.
The sample will consist of adult patients (≥18 years), of both sexes, with different musculoskeletal diagnoses involving joints, tendons, ligaments, cartilage or bone, among others.
详细描述
Orthobiological therapies, such as hyaluronic acid, platelet-rich plasma, bone marrow aspirate concentrate, and adipose tissue derivatives, have been widely used in the management of musculoskeletal pathologies, including tendinopathies, osteoarthritis, and delayed bone consolidation. However, scientific evidence is still limited by the heterogeneity of protocols, populations, and evaluation methods. This umbrella project aims to prospectively record and analyze the clinical and functional outcomes associated with the use of these therapies in patients treated according to institutional medical indications. Participants with different osteoarticular pathologies undergoing routine orthobiological treatment at the Proregen Medical Clinic and its affiliates will be included. The central hypotheses of the study are that orthobiological therapies present measurable clinical benefits in terms of pain, function, and quality of life in various osteoarticular indications; that the safety of these approaches is adequate when performed under defined clinical criteria; and that it is possible to identify patterns of greater efficacy according to the type of orthobiological agent, the pathology, and the follow-up time. As an expected conclusion, the study aims to generate real clinical data that can serve as a basis for derivative studies, in addition to contributing to the standardization and rationalization of the use of orthobiological therapies in orthopedic practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older;
- •Clinical and/or radiological diagnosis of an eligible musculoskeletal condition;
- •Formal clinical indication for treatment with orthobiological agents, according to routine care;
- •Regular access to the WhatsApp application, ensuring the necessary communication for sending and receiving digital questionnaires and other study instructions;
- •Ability to understand the study and sign the Informed Consent Form.
排除标准
- •Medical contraindication to the use of orthobiologics (e.g., active infection, severe hematological diseases, active cancer);
- •Recent use (≤3 months) of orthobiologic therapies in the same area to be treated;
- •Pregnant or breastfeeding women;
- •Cognitive or psychiatric diseases that prevent adequate clinical follow-up;
- •Simultaneous participation in another interventional clinical study with the same therapeutic purpose.
研究组 & 干预措施
Use of orthobiological products in musculoskeletal conditions.
After an evaluation by a medical professional, the patient will be advised on the best orthobiological treatment for their case.
干预措施: PRP injection (Biological)
Use of orthobiological products in musculoskeletal conditions.
After an evaluation by a medical professional, the patient will be advised on the best orthobiological treatment for their case.
干预措施: Bone Marrow Concentrate (BMAC) (Biological)
Use of orthobiological products in musculoskeletal conditions.
After an evaluation by a medical professional, the patient will be advised on the best orthobiological treatment for their case.
干预措施: Hyaluronic Acid (Viscosupplementation) (Biological)
Use of orthobiological products in musculoskeletal conditions.
After an evaluation by a medical professional, the patient will be advised on the best orthobiological treatment for their case.
干预措施: Nanofat (Biological)
结局指标
主要结局
Pain scale
时间窗: From registration until six months, one year, and two years. Two years is the final follow-up period.
Changes in pain scores six months after treatment with orthobiological materials. The following scale will be used: VAS - Visual Analog Scale (0 to 10 cm): The patient marks, with a line or dot, the location on the line that best represents the pain they are feeling at that moment. 0 cm → "no pain" / 10 cm → "worst pain imaginable".
Joint function
时间窗: Assessment at six months, one year, and two years. The total follow-up period is two years.
Changes observed in joint function in patients who received orthobiological treatment after 6 months. The following scales will be used: WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index): is a questionnaire specific to osteoarthritis, widely validated and used in clinical research. It assesses symptoms and functional impact of osteoarthritis. The WOMAC consists of 24 items, divided into 3 subscales: Pain - 5 items Stiffness - 2 items Physical function - 17 items Scoring is as follows: 0 = no pain 1. = mild pain 2. = moderate pain 3. = severe pain 4. = extreme pain Total score for the pain subscale: 0 to 20 points
次要结局
未报告次要终点