InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.

NCT01890733 | Terminated

• 1 other identifier: IS-CL-02
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear . The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily living(ADL) and improvement of range of motion (ROM).

Conditions

Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IV

Keywords

Massive Rotator Cuff Tear, Sub-acromial spacer, Best repair of rotator cuff,

Outcome Measures

Primary Outcomes (1)

• Comparison of respose rate at each treatment arm

  The primary efficacy outcome of the study is considered as the subject response/rehabilitation rate at 6 month post implantation as assesed by the change in the Shoulder Score

  6m

Secondary Outcomes (2)

• subjects requiring re-operation of the repaired tear at the end of the follow-up period.

  24 m post implantation

• change of total questionnaires scores from baseline to each follow-up visit.

  6W, 3m, 6m , 12m ,24m

Study Arms (2)

Best Repair of torn Rotator Cuff

SHAM COMPARATOR

Subjects will undergo surgical intervention (usually arthroscopy) to perform debridment, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair.

Device: Best Repair of torn Rotator Cuff

InSpace™ system

ACTIVE COMPARATOR

Subjects will undergo surgical intervention (usually arthroscopy or mini invasive) of debridment, acromioplasty if deemed necessary with or without long head of biceps tenotomy, and placement of the InSpace™ system.

Device: InSpace™ system

Interventions

Best Repair of torn Rotator Cuff DEVICE

Best Repair of torn Rotator Cuff

InSpace™ system DEVICE

InSpace™ system

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40 or older.
• Positive diagnostic imaging (CT arthrogram or MRI)\* of the affected shoulder indicating full thickness Massive RCT of at least 5cm in diameter (according to Cofield classification) or long - narrow tears of at least 4cm2 (W\>2cm and L\>2cm) including fatty infiltration grade III or IV (according to classification of Goutallier) involving more than one tendon. - Persistent pain and functional disability of the affected shoulder for at least 3 months.

You may not qualify if:

• Known allergy to the balloon material (copolymer of PLA and -θ-caprolactone).
• Evidence of significant osteoarthritis or cartilage damage in the shoulder
• Evidence of gleno-humeral instability
• Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy
• Evidence of major joint trauma, infection, or necrosis in the shoulder
• Partial-thickness tears of the rotator cuff

Sponsors & Collaborators

• OrthoSpace Ltd.: lead

Study Sites (1)

Policlinico

Milan, Italy

Location

Study Officials

• Luigi Solimeno, MD

  Policlinico de Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 2, 2013
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: June 4, 2020

Record last verified: 2012-09

Locations

IT (1)