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

Repair of a Cuff Tear Clinical Trial

— ESPACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04704700
• Other study ID #: 2020-A02443-36
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: July 2024

Study information

• Verified date: April 2023
• Source: Clinique Bizet
• Contact: bouchra benkessou
• Phone: 0033143967823
• Email: b.benkessou[@]clinique-bltparis.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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 -?-caprolactone copolymer)

• Osteoporosis

• Damaged cartilage

• Isolated rupture of the suprascapularis

• Glenohumeral instability

• Pseudo-paralytic shoulder- Infection

• Necrosis

• Major joint trauma

• Pregnant or breastfeeding women

Related Conditions & MeSH terms

• Repair of a Cuff Tear

Intervention

Device:
• repair of a cuff tear
Group (Treatment): Arthroscopic Implantation of the System InSpace on a repaired rotator cuff tendon
• repair of a cuff tear
Group (Control): standard Arthroscopic repair of the cuff rotator

Locations

Country	Name	City	State
France	Clinique Bizet	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Bizet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the re-rupture rate	with radiological imaging	12 months
Secondary	Evaluate mobility	the Constant score	up to 12 months
Secondary	Assess shoulder pain	VISUAL ANALOGIC SCALE	up to 12 months
Secondary	the quality of life assessed	Simple Shoulder Test, Subjective Shoulder Value and American Shoulder and Elbow Surgeons Shoulder Score	up to 12 months
Secondary	resumption of work	Physicians Global Assessment for resumption of work	up to 12 months