Inhibition of Inflammation for Prevention of Posttraumatic Osteoarthritis After Acute Intraarticular Fractures
试验速览
- 阶段
- 不适用
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Cytokines (identified in primary outcome 1) correlation with clinical outcomes (AOFAS)
研究概览
简要总结
Intra-articular fracture is a very common fracture. The only method to treat these fractures is surgery with plate and screws followed by rehabilitation. Even though the surgeons do their best to restore the anatomy, up to 40 percent of the patients develop osteoarthritis after 10 years. Previous research has shown that immediately after fracture in the joint, the body starts an inflammatory response and activates a series of biomarkers inside the joint space. Some of these biomarkers are believed to break down the cartilage resulting in development of osteoarthritis, despite surgical treatment. Currently it is still unknown, which biomarkers are activated in the joint space, and how we can stop their deleterious action in order to prevent cartilage degradation.
The purpose of this project is to identify the biomarkers in the joint space after an intra-articular ankle fracture and to evaluate how these biomarkers affect the short- and mid-terms clinical outcomes. As secondary outcomes we evaluate how fracture classification and fracture reduction affect clinical outcomes and physical activity after surgery.
详细描述
Osteoarthritis (OA) affecting one in eight individuals and is the main reason for chronic pain and disability worldwide. The main cause for OA development is joint-affecting trauma and risk factors have primarily been associated to previous biomechanical treatment. Therefore, the principle of current fracture treatment is anatomical reconstruction of the joint surface combined with functional and adequate aftercare. However, despite correct restoration of anatomy and application of sufficient physiotherapy, the risk of posttraumatic OA remains as high as 40%.
Joint trauma initiates an inflammatory cascade leading to synovial catabolism and cartilage degradation, a fact, which to date has been ignored in standard therapy. Unfortunately, due to the lack of blood supply, cartilage regenerates much less efficient compared to bone. Previous studies suggest that the synovial biochemical milieu may be of decisive importance for chondrocyte and cartilage survival or degeneration. The investigators therefore hypothesize, that protecting cartilage and chondrocyte by inhibiting the post-injury inflammatory cascade, might contribute to durable successful results in fracture therapy. The purpose of this project is to identify the biomarkers in the joint space after an intra-articular ankle fracture and to evaluate how these biomarkers affect the short- and mid-terms clinical outcomes. As secondary outcomes we evaluate how fracture classification and reduction affect clinical outcomes and physical activity after surgery. In specific, we intend to answer the following research questions:
Study 1: Are there differentially regulated biomarkers in joint space in patients with and without an intra-articular ankle fracture?
Study 2: Do the identified biomarkers found in intra-articular ankle fracture correlate with short- and middle term clinical symptoms after surgery?
Study 3: Does fracture classification and fracture reduction effect clinical outcomes and physical activity?
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 65 years
- •Existence of an acute fracture involving the ankle (location AO43,AO44) requiring open or closed reduction and internal or external fixation within 14 days
- •Being able to read and understand Danish
- •Informed consent
排除标准
- •Open fractures
- •Associated arterial and nerve injuries
- •Multiple injured patients with an Injury Severity Score >16
- •Primary or secondary infections
- •Injuries associated to a Charcot foot
- •Signs of existing OA on X-ray
结局指标
主要结局
Cytokines (identified in primary outcome 1) correlation with clinical outcomes (AOFAS)
时间窗: 12 months after surgery
The identified cytokines in the fracture ankle (fracture non fracture ratio above 2.0) will be coupled to the scores of functional foot score (AOFAS), The American Orthopedic Foot and Ankle Score, includes pain, function, alignment, for AOFAS calculation the subscores are added, ranges between 0 (worst) and 100 (best) points
Concentration of cytokines in fracture ankle versus non-fracture ankle
时间窗: During surgery
Multiplex ELISA kits will be use to identify cytokines in both ankles. Cytokines with significant difference will be identified.
次要结局
- Cytokines (identified in primary outcome 1) correlation with clinical outcomes (Swelling)(3 months after surgery)
- Cytokines (identified in primary outcome 1) correlation with clinical outcomes (EQ5D-5L)(3 months after surgery)
- Cytokines (identified in primary outcome 1) correlation with clinical outcomes (VAS-score)(3 months after surgery)
- Cytokines (identified in primary outcome 1) correlation with clinical outcomes (FFI.DK)(3 months after surgery)