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Completed

NCT Number: NCT02210910

InSpace™ System Over Rotator Cuff Repair in Comparison to Repair Alone.

This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ in the study population in comparison to surgical RCT repair.

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Key information

Conditions

Rotator Cuff Tear Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

40 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assuta Medical Center

Tel Aviv, 60710, Israel

About this study

The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily living (ADL) and improvement of range of motion (ROM).

Who can participate

Healthy volunteers accepted: No

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

Main Inclusion Criteria:

  • Age 40 or older.
  • Positive diagnostic MRI of the affected shoulder indicating full thickness large to massive RCT of at least 3cm in diameter (according to Cofield classification2) involving one or more tendons. (MRI can be done up to 6 months prior to randomization.)
  • Persistent pain and functional disability of the affected shoulder for at least 3 months.

Main Exclusion Criteria :

  • Known allergy to the balloon material (copolymer of PLA and -θ-caprolactone).
  • Evidence of significant osteoarthritis or cartilage damage in the shoulder
  • Evidence of gleno-humeral instability
  • Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy
  • Evidence of major joint trauma, infection, or necrosis in the shoulder
  • Partial-thickness tears of the rotator cuff

Treatment and study plan

InSpace™ system over repair

Device

Best Repair of torn Rotator Cuff

Procedure

Primary outcomes

  1. The change in the Shoulder Score

    Time frame: baseline and 6 months

Sponsors and collaborators

Lead sponsor

OrthoSpace Ltd.

Industry

Registry information

Official study title

A Randomized, Two-arm, Prospective Study to Assess the Efficacy and Safety of InSpace™ Device Implanted Over a Rotator Cuff Repair in Comparison With Rotator Cuff Repair Only

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Aug 7, 2014
Registry last updated
Aug 22, 2018

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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