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

April 11, 2023 updated by: Clinique Bizet
Evaluate the re-rupture rate 12 months following the intervention in a group with and a group without a spacer

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 12 months
with radiological imaging
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Bizet

Investigators

  • Principal Investigator: philippe VALENTI, DOCTOR, Clinique Bizet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

July 1, 2024

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)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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