In Vivo Clinical and Radiological Effects of Platelet-rich Plasma on Interstitial Supraspinatus Lesion: Randomized Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Lesion healing
研究概览
简要总结
Background and Rationale:
Tedious PRP infiltrations are emerging treatments for tendinopathies and tendon tears. It has been showed effective in different parts of the body, but current evidences for rotator cuff PRP infiltration remains poor. Some studies that tested infiltrations on transfixing lesions showed no statistically significant effect of PRP on tendon healing. The investigators believe that this might be explained by a "flushing effect" of PRP into subacromial space or glenohumeral joint. Therefore, it was decided to focus this study on interstitial lesions, in which PRP is entrapped into the lesion for a long time.
Objective:
The purpose of this study is to evaluate whether intra-tear PRP infiltrations promotes tear repair better than needling procedures of torn tendon in participants with supraspinatus interstitial tears.
As secondary objective, we will study symptoms alleviation in same way. Primary outcome: Primary outcome: Supraspinatus tear size change from baseline will be compared between cases receiving two PRP injections and controls receiving torn tendon needling, 6 months after second injection.
Secondary outcomes: Single Assessment Numeric Evaluation score, Constant score, ASES score, Shoulder pain disability index, and Visual analogue scale changes from baseline will be compared between cases receiving two PRP injections and controls receiving torn tendon needling, 0,1,3, and 6 months after second injection.
Study design: This case-control study is randomized 1:1 between PRP (intervention group) and needling (Control group). It is a superiority trial that will include 84 patients suffering from interstitial supraspinatus tears. As adjuvant therapy, patients from each arm will beneficiate from standard physical therapy program. PRP and needling will be repeated 2 times, at one month interval. First injection will occur up to two months after recruitment. Clinical follow-up will occur from second injection to one year after second injection, with clinical parameters evaluation at 0,1,3, and 6 months after second injection, and control MRI 6 months after second injection.
Study Product / Intervention: Supraspinatus tendon needling with intralesional PRP injection. PRP will be extracted with Regenlab® extraction kit. No other medications used.
Control Intervention (if applicable): Supraspinatus tendon needling with intralesional saline water injection.
Number of Participants with Rationale: 84 patients will be needed (37 in each group). A 10% of dropout has been taken in consideration.
Study Duration: 24 months from recruitment of the first patient to the last follow-up visit. Scientific report will be written within the two months following recruitment of the last patient.
Study Schedule: First-Participant-In: 01.6.2015 Last-Participant-Out: 30.6.2017
详细描述
DETAILLED PLANNED STATISTICAL METHODS
Hypothesis
Null hypothesis: In patients with interstitial rotator cuff tear, there is no difference in term of tendon tear size percentage between baseline and 6 months after intervention.
Alternative hypothesis: In patients with interstitial rotator cuff tear, there is a difference in term of tendon of tendon tear size percentage between baseline and 6 months after intervention.
Determination of Sample Size
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Informed Consent as documented by signature (Appendix Informed Consent Form),
- •Symptomatic interstitial tear of the supraspinatus tendon,
排除标准
- •Tear of infraspinatus or subscapularis tendons (same shoulder)
- •Frozen shoulder (antepulsion deficit > 20%)
- •Corticosteroid shoulder infiltration in the 3 months prior the inclusion,
- •Patients suffering from symptomatic anaemia, or patients with severe cardiorespiratory insufficiency,
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Patients incapable of judgement or under tutelage,
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- •Previous enrolment into the current study,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons,
研究组 & 干预措施
PRP infiltration
Supraspinatus interstitial lesion needling and infiltration with PRP
干预措施: PRP infiltraiton (Procedure)
Needling
Supraspinatus interstitial lesion needling and infiltration with NaCl
干预措施: Needling (Procedure)
结局指标
主要结局
Lesion healing
时间窗: 6 months
After second PRP injection, tendon healing will be assessed by comparison of baseline MRI and control MRI
次要结局
- ASES score(0,1,3, and 6 months)
- Shoulder Pain Disability Index score(0,1,3, and 6 months)
- Time limit in months from the first intervention to the last follow-up(12-36 months)
- Treatements at the end of the 6 months of PRP/Saline follow-up: Occurence of other infiltrations(between 6 months and the last follow-up)
- Single Assessment Numeric Evaluation (SANE) score(0,1,3, and 6 months, and last follow-up (12 months or more))
- Correlation between the initial tear size and the percentage of tear size evolution(6 months)
- Histological changes of tendon samples in case of surgery: tendon cellularity(between 6 months and the last follow-up)
- Histological changes of tendon samples in case of surgery: apoptosis(between 6 months and the last follow-up)
- Pain Scores on the Visual Analogue Scale(0,1,3, 6 months, and last follow-up (12 months or more))
- Constant score(0,1,3, and 6 months)
- Lesion healing between interstitial lesions that englobes or not the bone-tendon interface(6 months)
- Treatements at the end of the 6 months of PRP/Saline follow-up: Occurence of corticoid infiltrations(between 6 months and the last follow-up)
- Histological changes of tendon samples in case of surgery: vascularity(between 6 months and the last follow-up)
- Treatements at the end of the 6 months of PRP/Saline follow-up: Occurence of surgery(between 6 months and the last follow-up)
研究者
Adrien Schwitzguebel
MD
La Tour Hospital