NCT04704700

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

3.8 years

First QC Date

January 8, 2021

Last Update Submit

December 31, 2025

Conditions

Repair of a Cuff Tear

Outcome Measures

Primary Outcomes (1)

  • Evaluate the re-rupture rate

    with radiological imaging

    12 months

Secondary Outcomes (4)

  • Evaluate mobility

    up to 12 months

  • Assess shoulder pain

    up to 12 months

  • the quality of life assessed

    up to 12 months

  • resumption of work

    up to 12 months

Study Arms (2)

patient with inspace device

ACTIVE COMPARATOR
Device: repair of a cuff tear

patient without inspace device

PLACEBO COMPARATOR
Device: repair of a cuff tear

Interventions

repair of a cuff tearDEVICE

Group (Treatment): Arthroscopic Implantation of the System InSpace on a repaired rotator cuff tendon

patient with inspace device

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Bizet

Paris, 75016, France

Location

Study Officials

  • philippe VALENTI, DOCTOR

    Clinique Bizet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 12, 2021

Study Start

September 1, 2021

Primary Completion

June 30, 2025

Study Completion

December 31, 2025

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations

FR(1)