Amendment to the Study "Prospective, Multicenter Investigation of Clinical Rehabilitation and Everyday Recovery Following Knee Joint Endoprosthetic Replacement" With Additional Return-to-sports-testing at One Participating Center
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Level of sports 1-4
研究概览
简要总结
The ability to return to sports after joint arthroplasty is increasingly becoming an important factor for patients in terms of their perceived quality of life. In sports orthopaedics, standardized functional tests have already been established - particularly for anterior cruciate ligament injuries - to assess athletic performance and prevent re-injury. These tests allow a stepwise evaluation of a subject's physical readiness for sports.
In the field of arthroplasty, and despite increasing sports activity among patients with joint arthroplasty such structured assessment is still lacking. As a result, patients with arthroplasty typically resume sports activities based solely on individual recommendations from the surgeon or treating therapist. However, an objective evaluation of sports capability is currently not available.
Therefore the amendment intends to expand the current testing protocol of the already registered and ongoing study (Protocol ID: UBonn_TKA_FollowUp) to include additional standardized, evidence-based return-to-sprort-tests.
详细描述
These return-to-sports-tests are based on validated procedures commonly used in sports orthopaedics, particularly following the stepwise testing concept described by Keller et al..
Initially, the participant's individual sport level is determined via structured anamnesis. This is then followed by level-specific functional testing. Participants who do not perform Level 1 testing correctly will not proceed to Level 2 testing -even if their anamnesis suggests a higher sport level. This stepwise approach ensures safety and prevents injury during the testing process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study includes all patients with a history of unicondylar or bicondylar knee joint replacement and engagement in sports activity.
- •All participating patients have provided their informed consent following comprehensive information and explanation.
- •All participating patients have signed the informed consent form for study participation as well as the data protection declaration after receiving detailed information and clarification.
排除标准
- •Patients who are unable to understand the patient information and study design (e.g., due to language barriers) or whose compliance is deemed insufficient by the study team
- •No knee joint endoprosthesis implanted
- •No engagement in athletic activity
研究组 & 干预措施
RTS
Return-to-sports-tested patients
干预措施: Return to sports test (Diagnostic Test)
结局指标
主要结局
Level of sports 1-4
时间窗: Baseline at the time of measurement
Levels of sports are divided into four levels: 1. Sports without jumping; 2. Dynamic sports without pivoting or abrupt stopping movements; 3. Sports involving lateral movements and moderate pivoting or stopping motions (less intense than in Level 4); 4. Sports with jumping, rapid pivoting, and sudden stopping movements.
次要结局
未报告次要终点