힘줄 장애의 통증 및 제한된 이동성 치료에 대한 OSTENIL® TENDON의 효과 및 안전성
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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Raphaela Geiger
- 전화번호: +49 89-461483-27
- 이메일: geiger@trbchemedica.de
연구 연락처 백업
- 이름: Veronika Mussack, Dr.
- 전화번호: +49 89-461483-43
- 이메일: mussack@trbchemedica.de
연구 장소
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Berlin, 독일, 13589
- 완전한
- Orthopädie am Kiesteich
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Berlin, 독일, 10627
- 완전한
- ATOS MVZ meviva Berlin
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Berlin, 독일, 14197
- 완전한
- Gemeinschaftspraxis Dr. Bierke
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Potsdam, 독일, 14482
- 완전한
- Orthopädische Praxis Dr. Fischer
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State of Berlin
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Berlin, State of Berlin, 독일, 14195
- 모병
- Orthopädisches Versorgungszentrum und Interdisziplinäres Schmerzzentrum Zehlendorf
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연락하다:
- Christopher Kohler, Dr. med.
- 전화번호: +49 30 81051850
- 이메일: kohler@ortho-zentrum-zehlendorf.de
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Berlin, State of Berlin, 독일, 14195
- 완전한
- Orthopädische Gemeinschaftspraxis ÜBAG
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients over 18 years of age with symptomatic tendinopathy (patella tendon, peroneal tendon, medial epicondylus humeri or iliotibial band) and a recommendation for OSTENIL® TENDON treatment.
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
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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
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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
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Diagnosis of chronic inflammatory disease (e.g. rheumatoid arthritis, Bechterew disease, Crohn's disease, etc.) prior to inclusion
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Participation in a clinical investigation within the last 6 months
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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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_ONLY
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
OSTENIL® TENDON
2 injections of sodium hayluronate 2 % (40 milligrams (mg) / 2.0 millilitres (ml)) in weekly interval. |
OSTENIL® TENDON is a CE-certified viscoelastic solution intended for peritendinous or intrasheath injection, containing 2 % sodium hyaluronate from fermentation. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change of pain intensity 3 months after end of treatment compared to baseline (visual analogue scale)
기간: 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. |
Baseline compared to week 12 after the end of treatment.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
기기 또는 적용 절차와 인과관계가 있는(가능한/가능성 있는) 이상반응의 발생
기간: 치료 종료 후 24주까지.
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치료 종료 후 24주까지.
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|
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기기 또는 적용 절차와 인과관계가 있는(가능한/가능성 있는) 심각한 부작용 발생
기간: 치료 종료 후 24주까지.
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치료 종료 후 24주까지.
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(아마도) 심각한 사고 발생
기간: 치료 종료 후 24주까지.
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치료 종료 후 24주까지.
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장치 결함 발생률
기간: 치료 종료 후 24주까지.
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치료 종료 후 24주까지.
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Change of Upper -/ Lower Extremity Functional Scale compared to baseline
기간: Baseline compared to week 1 as well as weeks 4, 12 and 24 after the end of treatment.
|
Indication specific patient questionnaire to assess effectiveness of treatment on a 5-point Likert scale (range: 0 = extreme difficulty to perform activity to 4 = no difficulty). |
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)
기간: Baseline compared to week 1 as well as weeks 4 and 24 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. |
Baseline compared to week 1 as well as weeks 4 and 24 after the end of treatment.
|
|
Change of patient-reported outcome measures (PROM)
기간: Baseline (except satifaction with treatment), week 1 and weeks 4, 12 and 24 after the end of treatment.
|
Patient questionnaire to assess the following aspects (100 mm visual analogue scale; 100 mm equals a worse outcome): pain, global and tendon-associated quality of life, daily activities, clinical global impression, mobility and satisfaction with treatment (note: not assessed at baseline) |
Baseline (except satifaction with treatment), week 1 and weeks 4, 12 and 24 after the end of treatment.
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Change of investigator-reported outcome measures
기간: Baseline (except satisfaction with treatment), week 1 and weeks 4, 12 and 24 after the end of treatment.
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Investigator inquiry to record the perception of the physician of the following aspects (100 mm visual analogue scale; 100 mm equals a worse outcome): clinical global impression regarding the clinical severity of the tendinopathy and satisfaction with the treatment (note: not assessed at baseline) |
Baseline (except satisfaction with treatment), week 1 and weeks 4, 12 and 24 after the end of treatment.
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Degree of tendinopathy
기간: Baseline, week 1 and weeks 4, 12 and 24 after the end of treatment
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Evaluation of tendinopathy symptoms by the patient by rating tendon pain in the context of a patient-defined task that usually elicits pain (4 stages; 4 equals a worse outcome) |
Baseline, week 1 and weeks 4, 12 and 24 after the end of treatment
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Olaf Neubert, Dr. med., Orthopädie am Kiesteich
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .