InSpace™ System Implantation in a Procedure Under Local Anesthesia

NCT ID: NCT02208453

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2019-04-30

Brief Summary

The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected shoulder.

Detailed Description

A single arm, open-label, prospective, study to assess the feasibility, efficacy and safety of InSpace™ device implantation in a procedure under local anesthesia for a treatment of subjects with massive, irreparable rotator cuff tear.

Subjects with radiological confirmed massive RCT who are eligible per inclusion/exclusion criteria, will be enrolled for the study treatment.

Subjects will undergo surgical intervention under local anesthesia , fluoroscopic and/ or arthroscopic visualization of InSpace™ implantation.

Subjects will then be followed for safety and efficacy for a 24 months following the implantation.

The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device implantation in a surgical procedure under local anesthesia using arthroscopic and/or fluoroscopic visualization of the affected shoulder.

The efficacy will be assess by using Constant and ASES outcome score The Constant and the ASES will be completed by the investigator at each study visit .The patient will complete the patient self-evaluation part of the ASES at each study visit.

The Safety assessment will be conducted by collecting all device related AEs/SAEs throughout the entire study period.

Conditions

Rotator Cuff Tear

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

InSpace implantation

InSpace device implantation

Group Type: EXPERIMENTAL

InSpace Implantation

Intervention Type: DEVICE

InSpace device Implantation

Interventions

InSpace Implantation

InSpace device Implantation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 50 or older.

2. Positive diagnostic MRI of the affected shoulder indicating full thickness massive irreparable RCT of at least 5cm in diameter (according to Cofield classification) including fatty infiltration grade III or IV (according to classification of Goutallier).

3. Persistent pain and failure of non-operative treatment of the affected shoulder for at least 3 months.

Exclusion Criteria

1. Known allergy to the balloon material

2. Evidence of significant osteoarthritis or cartilage damage in the shoulder

3. Evidence of gleno-humeral instability

4. Evidence of major joint trauma, infection, or necrosis in the shoulder

5. Major medical condition or known drug or alcohol abuses that could affect quality of life and influence the results of the study.

6. Concurrent participation in any other invasive clinical study one month prior to enrollment to the study and during the entire study period.

7. Subjects with worker's compensation claims or other litigation claims related to the shoulder being treated in the study.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OrthoSpace Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enrico Gervasi, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Department, Latisana Hospital

Locations

Hospital of Latisana

Latisana, Udine, Italy

Countries

Italy

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/27900707

Fluoroscopy-guided biodegradable spacer implantation using local anesthesia: safety and efficacy study in patients with massive rotator cuff tears.

Other Identifiers

72746

Identifier Type: OTHER

Identifier Source: secondary_id

IS-CL-05

Identifier Type: -

Identifier Source: org_study_id