Clinical trial NCT02208453: InSpace™ System Implantation in a Procedure Under Local Anesthesia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: Massive Rotator Cuff Tear
Local anesthesia
Sub-acromial spacer
Lead sponsor: OrthoSpace Ltd.
Sponsor class: INDUSTRY
First posted: 2014-08-05
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in total shoulder outcome scores (Constant and ASES)
timeFrame: 6 months post implanatation
Secondary outcomes:
measure: Change in Total Shoulder scores
timeFrame: up to 24 months post implantation
Other outcomes:
measure: Safety Assessment
timeFrame: 24 months post implantation
Locations:
city: Latisana
country: Italy
facility: Hospital of Latisana
state: Udine
Study officials:
affiliation: Orthopedic Department, Latisana Hospital
name: Enrico Gervasi, MD
role: PRINCIPAL_INVESTIGATOR
References: