NCT06681051招募中不适用
Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 12
- 主要终点
- Change of pain intensity 3 months after end of treatment compared to baseline (visual analogue scale)
研究概览
简要总结
PMCF study to further substantiate the effectiveness and safety of OSTENIL® TENDON in the overall as well as indication-specific treatment of pain and restricted mobility in four different tendon disorders (patella tendon, peroneal tendon, medial epicondylus humeri and iliotibial band) in a real-life clinical setting when used according to the instructions for use.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged between 18 and 99 years
- •Diagnosis of symptomatic tendinopathy (patella tendon, peroneal tendon, medial epicondylus humeri or iliotibial band)
- •Physician's recommendation to use OSTENIL® TENDON prior to recruitment
- •Signed informed consent
排除标准
- •Presence of any contra-indication or precautionary condition listed in the instructions for use, i.e.,
- •Ascertained hypersensitivity to any of the OSTENIL® TENDON constituents
- •Known pregnancy or breast feeding
- •Acute trauma
- •Use of the following treatments (the given time intervals refer to the date of inclusion):
- •Local* OSTENIL® TENDON or other hyaluronic acid (HA) treatment within the last 6 months
- •Local* platelet-rich plasma (PRP) treatment within the last 3 months
- •Local* corticosteroid treatment (without time restriction)
- •Local* extracorporeal shock wave therapy (ESWT) within the last 4 weeks
- •Local* phytotherapy (e.g., Traumeel®) within the last 4 weeks
- •Local* surgical intervention (without time restriction)
- •Systemic corticosteroid treatment within the last 4 weeks
- •Repeated use of non-steroidal anti-inflammatory drugs (NSAID) and/or other analgesics within the last week
- •Physiotherapy (therapeutic exercises and physical therapy), ortheses, transcutaneous electrical nerve stimulation (TENS) or acupuncture within the last week
- •Diagnosis of chronic inflammatory disease (e.g. rheumatoid arthritis, Bechterew disease, Crohn's disease, etc.) prior to inclusion
- •Participation in a clinical investigation within the last 6 months
- •Vulnerable patient (individual who is unable to fully understand all aspects of the study that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response [including persons needing legally designated representatives, illiterate persons or persons with insufficient knowledge of local language])
- •(* local refers to the treatment of the study-relevant tendon)
研究组 & 干预措施
OSTENIL® TENDON
2 injections of sodium hayluronate 2 % (40 milligrams (mg) / 2.0 millilitres (ml)) in weekly interval.
干预措施: OSTENIL® TENDON (Device)
结局指标
主要结局
Change of pain intensity 3 months after end of treatment compared to baseline (visual analogue scale)
时间窗: Baseline compared to week 12 after the end of treatment.
Evaluation of pain intensity by the patient on a 100 mm visual analogue scale. 100 mm equals the worst pain.
次要结局
- Change of Upper -/ Lower Extremity Functional Scale compared to baseline(Baseline compared to week 1 as well as weeks 4, 12 and 24 after the end of treatment.)
- Change of pain intensity compared to baseline (visual analogue scale)(Baseline compared to week 1 as well as weeks 4 and 24 after the end of treatment.)
- Change of patient-reported outcome measures (PROM)(Baseline (except satifaction with treatment), week 1 and weeks 4, 12 and 24 after the end of treatment.)
- Change of investigator-reported outcome measures(Baseline (except satisfaction with treatment), week 1 and weeks 4, 12 and 24 after the end of treatment.)
- Degree of tendinopathy(Baseline, week 1 and weeks 4, 12 and 24 after the end of treatment)
- Incidence of Adverse Events with (possible/probable) causal relationship with the device or application procedure(Up to week 24 after the end of treatment.)
- Incidence of Serious Adverse Events with (possible/probable) causal relationship with the device or application procedure(Up to week 24 after the end of treatment.)
- Incidence of (Presumably) serious incidents(Up to week 24 after the end of treatment.)
- Incidence of Device Deficiencies(Up to week 24 after the end of treatment.)
研究者
研究点 (12)
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