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

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

Official title:

A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Efficacy and Safety of InSpace™ Device in Comparison to Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01890733
• Other study ID #: IS-CL-02
• Status: Terminated
• Phase: N/A
• Start date: September 2012
• Est. completion date: September 2015

Study information

• Verified date: September 2012
• Source: OrthoSpace Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 95 Years

Eligibility

Main Inclusion Criteria:

• 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.

Main Exclusion Criteria :

• Known allergy to the balloon material (copolymer of PLA and -?-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

Related Conditions & MeSH terms

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

Intervention

Device:
• Best Repair of torn Rotator Cuff

• InSpace™ system

Locations

Country	Name	City	State
Italy	Policlinico	Milano

Sponsors (1)

Lead Sponsor	Collaborator
OrthoSpace Ltd.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	subjects requiring re-operation of the repaired tear at the end of the follow-up period.	Comparison of number of subjects requiring re-operation of the repaired tear at the end of the follow-up period at each tratment arm.	24 m post implantation
Secondary	change of total questionnaires scores from baseline to each follow-up visit.	Comparison between the change of total questionnaires scores from baseline to each follow-up visit at each treatment arm.	6W, 3m, 6m , 12m ,24m