Clinical Trial on the Effect of REGENETEN Bioinductive Implant in the Supraspinatus Tendon Repair.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Integrity of the tendon repaired in an MRI study one year after the intervention using the Sugaya classification (Sugaya H (2005)).
研究概览
简要总结
This study aims a determine the effect that the addition of REGENETEN Bioinductive Implant has on Supraspinatus Tendon Repair. 120 patients will be included in this prospective, randomized, parallel group study.
详细描述
The rotator cuff tear is one of the most frequent pathologies in the shoulder joint. When there are many symptoms these breaks are repaired surgically. The success rate of healing of these injuries is between 30% and 80%. In two recent studies conducted at two of the centers participating in this trial, the success rate of repair was 75% (unpublished data) and 70% respectively.
The use of high porosity resorbable bovine collagen meshes as bioinductive scaffolds for cuff repair seems to be a valid alternative when trying to improve the success rate in the healing of rotator cuff injuries.
REGENETEN Bioinductive Implant (a high porosity reconstituted type I collagen mesh of bovine origin) is applied to the repaired tendon. In a pilot study of 9 subjects with full thickness supraspinatus ruptures who underwent tendon repair and subsequently had the implant associated with the rupture, a significant clinical improvement was observed after one year and was observed on magnetic resonance imaging ( RM) 100% healing of breaks. In a study of 33 subjects with partial thickness tears treated with the implant alone, improvement in MRI characteristics of the tendon was observed in 31 cases. There is a study that performs a histological analysis of samples obtained in 7 subjects in whom the implant was used. No evidence of foreign body reaction or inflammatory reaction was observed. In none of the three studies where said implant was used in humans were any complications or adverse effects related to the use of said implant observed.
The objective of the study is to evaluate the effect that the addition of REGENETEN bovine collagen mesh has on tendon repair on MRI performed one year after surgery.
The study does not in itself pose a greater risk than the usual practice for the patient, since in these subjects where the implant could be used as a supplement to the repair, having already obtained the CE marking.
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
- Triple (Participant, 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
- •Patients who, after having received information about the design, the purposes of the study, the possible risks that may arise from it, and who may at any time deny their collaboration, give their written consent to participate in the study.
- •>18 years
- •Patients who present:
- •Symptomatic ruptures of the supraspinatus muscle (SE) with or without involvement of the infraspinatus (IE) with anteroposterior size of the rupture of 1 to 4 cm.
- •With less than 3cm of retraction,
- •With the absence of severe muscular atrophy confirmed by magnetic resonance imaging or CT (Absence of Goutalier grade I or II atrophy in muscle mass). MRI or CT must have been performed at most 6 months before the intervention.
- •That it be confirmed during the exploratory arthroscopy at the beginning of the intervention.
- •That after repair a coverage of the native footprint of the tendon of at least 80% is obtained
- •No presence of rupture that requires repair in the tendons of the subscapularis muscles or minor round
- •Understand the purpose of the study and be available for regular hospital visits.
- •Negative urine pregnancy test performed in the 7 days prior to the start of study treatment in premenopausal women or <2 years after menopause
排除标准
- •Pregnancy or planning to become pregnant during the course of the study.
- •SE tendon tears of more than 3cm retraction
- •Tendon ruptures of the SE and IE muscles with anteroposterior size of the rupture greater than 4 cm.
- •SE and / or IE tendon ruptures that are considered irreparable or only partially repairable at the time of the intervention
- •Presence of ruptures of the subscapularis and / or minor round tendons
- •Presence of grade III or IV Goutallier atrophy in the supraspinatus muscle mass
- •History of other orthopedic pathologies in the affected shoulder (previous shoulder surgeries, fractures, tendon re-ruptures of the supraspinatus or other tendons, rheumatic diseases, septic arthritis, ...)
结局指标
主要结局
Integrity of the tendon repaired in an MRI study one year after the intervention using the Sugaya classification (Sugaya H (2005)).
时间窗: 12 months
This is a classification system described by Sugaya et al. which uses magnetic resonance imaging in order to evaluate tendon integrity after rotator cuff repair. Postoperative cuff integrity is classified into 5 categories: type I, sufficient thickness with homogenously low intensity; type II, sufficient thickness with partial high intensity; type III, insufficient thickness without discontinuity; type IV, presence of minor discontinuity; type V, presence of major discontinuity
次要结局
- Functional changes, measured with the Constant-Murley Scale.(3 months, 6 months and 12 months after surgery.)
- Functional changes, measured with ASES questionnaire.(3 months, 6 months and 12 months after surgery.)
- Change in pain levels. Measured with questions 3 to 6 of the Brief Pain Inventory.(3 months, 6 months and 12 months after surgery)
- Changes in quality of life measured with EQ-5D-5L questionnaire.(3 months, 6 months and 12 months after surgery.)
- Number of patients with complications in both arms(12 months)