Evaluate the Rotator Cuff Repair With "InSpace" VS Without "InSpace" (ESPACE)

Evaluate the re-rupture rate 12 months following the intervention in a group with and a group without a spacer

Study Overview

• Status: Completed
• Conditions: Repair of a Cuff Tear
• Intervention / Treatment: Device: repair of a cuff tear; Device: repair of a cuff tear

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75016
    • Clinique Bizet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• First intention of the rotator cuff
• Repairable supraspinatus and infraspinatus type 2 rupture (according to the PATTE classification, tendon retraction at the top of the humeral head)
• No surgical history
• Patient who has given his participation agreement to participate in the observational study after information by the surgeon,
• Patient living in France and having the capacity to answer alone to the survey.
• Subject affiliated to a social security scheme
• Lack of participation in another clinical study

Exclusion Criteria:

• Major subject protected by law, under curatorship or tutorship
• Known allergy to Inspace medical device materials (PLA and -θ-caprolactone copolymer)
• Osteoporosis
• Damaged cartilage
• Isolated rupture of the suprascapularis
• Glenohumeral instability
• Pseudo-paralytic shoulder- Infection
• Necrosis
• Major joint trauma
• Pregnant or breastfeeding women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: patient with inspace device	Device: repair of a cuff tear; Group (Treatment): Arthroscopic Implantation of the System InSpace on a repaired rotator cuff tendon; Device: repair of a cuff tear; Group (Control): standard Arthroscopic repair of the cuff rotator
Placebo Comparator: patient without inspace device	Device: repair of a cuff tear; Group (Treatment): Arthroscopic Implantation of the System InSpace on a repaired rotator cuff tendon; Device: repair of a cuff tear; Group (Control): standard Arthroscopic repair of the cuff rotator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the re-rupture rate	with radiological imaging	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate mobility	the Constant score	up to 12 months
Assess shoulder pain	VISUAL ANALOGIC SCALE	up to 12 months
the quality of life assessed	Simple Shoulder Test, Subjective Shoulder Value and American Shoulder and Elbow Surgeons Shoulder Score	up to 12 months
resumption of work	Physicians Global Assessment for resumption of work	up to 12 months

Collaborators and Investigators

• Sponsor: Clinique Bizet
• Investigators: Principal Investigator: philippe VALENTI, DOCTOR, Clinique Bizet

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2020-A02443-36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No