InSpace™ System Implantation in a Procedure Under Local Anesthesia

NCT02208453 | Completed

• 2 other identifiers: IS-CL-0572746
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear

Keywords

Massive Rotator Cuff Tear; Local anesthesia; Sub-acromial spacer

Outcome Measures

Primary Outcomes (1)

• Change in total shoulder outcome scores (Constant and ASES)

  Change in total shoulder outcome scores (Constant and ASES)at 6 month post implantattion

  6 months post implanatation

Secondary Outcomes (1)

• Change in Total Shoulder scores

  up to 24 months post implantation

Other Outcomes (1)

• Safety Assessment

  24 months post implantation

Study Arms (1)

InSpace implantation

EXPERIMENTAL

InSpace device implantation

Device: InSpace Implantation

Interventions

InSpace Implantation DEVICE

InSpace device Implantation

InSpace implantation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 or older.
• 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).
• Persistent pain and failure of non-operative treatment of the affected shoulder for at least 3 months.

You may not qualify if:

• Known allergy to the balloon material
• Evidence of significant osteoarthritis or cartilage damage in the shoulder
• Evidence of gleno-humeral instability
• Evidence of major joint trauma, infection, or necrosis in the shoulder
• Major medical condition or known drug or alcohol abuses that could affect quality of life and influence the results of the study.
• Concurrent participation in any other invasive clinical study one month prior to enrollment to the study and during the entire study period.
• Subjects with worker's compensation claims or other litigation claims related to the shoulder being treated in the study.

Sponsors & Collaborators

• OrthoSpace Ltd.: lead

Study Sites (1)

Hospital of Latisana

Latisana, Udine, 33503, Italy

Location

Related Links

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

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Enrico Gervasi, MD

  Orthopedic Department, Latisana Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2013
• First Posted: August 5, 2014
• Study Start: January 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: April 1, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

IT (1)