NCT04444076

Clinical Trial on the Effect of REGENETEN Bioinductive Implant in the Supraspinatus Tendon Repair

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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In two recent studies conducted at two of the centers participating in this trial, the success rate of repair was 75% (unpublished data) and 70% respectively.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.

Conditions

• Supraspinatus Tear

Interventions

Type	Name	Description
DEVICE	REGENETEN Bioinductive Implant	REGENETEN bioinductive Implant,a reconstituted bovine origin type I collagen mesh with a proprietary high porosity system that is commercialized sterile, dehydrated and desiccated in two sizes (20x26mm and 25x31mm). It will be implanted following supraspinatus tendon repair.

Timeline

• Start date: 2020-06-17
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2020-06-23
• Last updated: 2024-09-19

Locations

1 site across 1 country: Spain