A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears

O

OrthoSpace

Status

Completed

Conditions

Rotator Cuff Syndrome

Treatments

Device: InSpace sub-acromial tissue spacer system
Procedure: Partial repair of rotator cuff

Study type

Interventional

Funder types

Industry

Identifiers

NCT02493660
CLD-OR-010

Details and patient eligibility

About

A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical partial repair of full thickness Massive Rotator Cuff Tear (MRCT).

Full description

This is a non-inferiority, prospective, single blinded, multi-center, randomized, controlled, pivotal study evaluating the safety and effectiveness of the InSpace™ device as a primary surgical treatment for full thickness MRCT in comparison to Partial Repair of a full thickness MRCT performed during an arthroscopic procedure.

Enrollment

184 patients

Sex

All

Ages

40 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

  • Positive diagnostic imaging by MRI of the index shoulder indicating a full thickness Massive Rotator Cuff Tear (MRCT), measuring ≥ 5 cm in diameter involving ≥ two tendons (confirmed Intra-operatively)
  • Functional deltoid muscle and preserved passive range of motion on physical examination
  • Documented VAS score of > 30 mm pain
  • Failed non-operative treatment of at least 4 months
  • Patient in general good health,independent, and can comply with all post-operative evaluations and visits.

Main Exclusion Criteria:

Known allergy to the device material (copolymer of PLA and -ε-caprolactone)

Evidence of the following conditions:

  • significant gleno-humeral or acromiohumeral arthritis
  • full thickness cartilage loss as seen on MRI
  • gleno-humeral instability (excessive translation of the humeral head on the glenoid fossa)
  • pre-existing deltoid defect or deltoid palsy
  • major joint trauma, infection or necrosis
  • partial thickness tears of the supraspinatous
  • fully reparable rotator cuff tear [Tear of less than 5 cm in diameter (or < 4 cm2) with retractable tendon that can be fully repaired]
  • The subject requires concomitant subscapularis repair and/or labral repair
  • Previous surgery of the index shoulder in the past 1 year, excluding diagnostic arthroscopy
  • The subject's condition is bilateral and rotator cuff repair is scheduled or to be scheduled over the course of this study for the contra lateral shoulder
  • Major medical condition that could affect quality of life and influence the results of the study (e.g. HIV or other immunosuppressive conditions, active malignancy in the past 5 years, acute MI, CVA, etc.)
  • Documented evidence of a history of drug/alcohol abuse within 12 months of enrollment
  • The subject's condition represents a worker's compensation case
  • The subject is currently involved in a health-related litigation procedure
  • Females of child-bearing potential who are pregnant or breastfeeding or plan to become pregnant during the course of the study
  • Concurrent participation in any other investigational clinical study one month prior to enrollment or during the entire study period
  • The subject has implanted metallic devices (e.g., cardiac pacemakers, insulin pumps, nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing a MRI scan or has claustrophobia that would inhibit ability to undergo a MRI scan .
  • The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant to follow-up
  • The subject is receiving prescription narcotic pain medication for conditions unrelated to the index shoulder condition
  • The subject currently has an acute infection in the area surrounding the surgical site.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

184 participants in 2 patient groups

InSpace implantation
Experimental group
Description:
Arthroscopic InSpace (Sub-acromial tissue spacer system) implantation
Treatment:
Device: InSpace sub-acromial tissue spacer system
Tendon Repair
Active Comparator group
Description:
Arthroscopic partial repair of rotator cuff
Treatment:
Procedure: Partial repair of rotator cuff

Trial documents
2

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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