Clinical trial NCT04444076: Clinical Trial on the Effect of REGENETEN Bioinductive Implant in the Supraspinatus Tendon Repair
Official title: Clinical Trial on the Effect of REGENETEN Bioinductive Implant in the Supraspinatus Tendon Repair
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Supraspinatus Tear
Keywords: Supraspinatus Tear
REGENETEN
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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In two recent studies conducted at two of the centers participating in this trial, the success rate of repair was 75% (unpublished data) and 70% respectively.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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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, ...)

Primary outcomes:
measure: Integrity of the tendon repaired in an MRI study one year after the intervention using the Sugaya classification (Sugaya H (2005)).
timeFrame: 12 months
Secondary outcomes:
measure: Change in pain levels. Measured with questions 3 to 6 of the Brief Pain Inventory.
timeFrame: 3 months, 6 months and 12 months after surgery
measure: Functional changes, measured with the Constant-Murley Scale.
timeFrame: 3 months, 6 months and 12 months after surgery.
measure: Functional changes, measured with ASES questionnaire.
timeFrame: 3 months, 6 months and 12 months after surgery.
measure: Changes in quality of life measured with EQ-5D-5L questionnaire.
timeFrame: 3 months, 6 months and 12 months after surgery.
measure: Number of patients with complications in both arms
timeFrame: 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
Study officials:
affiliation: Hospital Ramón y Cajal, Spain
name: Miguel Angel Ruiz Iban, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: