Evaluate the Rotator Cuff Repair With "InSpace" VS Without "InSpace"

Not Applicable

Recruiting

• Conditions: Repair of a Cuff Tear
• Interventions: Device: repair of a cuff tear

• Registration Number: NCT04704700
• Lead Sponsor: Clinique Bizet

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-12
• Study Start: 2021-09-01
• Status Verified: 2024-11
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patient with inspace device	repair of a cuff tear	-
patient without inspace device	repair of a cuff tear	-

Primary Outcome Measures

Name	Time	Method
Evaluate the re-rupture rate	12 months	with radiological imaging

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinique Bizet; 🇫🇷 Paris, France