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OpenTrials
Completed

NCT Number: NCT04704700

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

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

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Key information

Conditions

Repair of a Cuff Tear

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Bizet

Paris, 75016, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repair of a cuff tear

Device

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

Primary outcomes

  1. Evaluate the re-rupture rate

    Time frame: 12 months

    with radiological imaging

Secondary outcomes

  1. Evaluate mobility

    Time frame: up to 12 months

    the Constant score

  2. Assess shoulder pain

    Time frame: up to 12 months

    VISUAL ANALOGIC SCALE

  3. 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

  4. resumption of work

    Time frame: up to 12 months

    Physicians Global Assessment for resumption of work

Sponsors and collaborators

Lead sponsor

Clinique Bizet

Other

Registry information

Acronym: ESPACE

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2021
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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