InSpace Accelerated Rehabilitation Study
ConditionRotator Cuff Tears
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorStryker Endoscopy
About this trial
This is a prospective, parallel group, open-label, multi- center, randomized study to assess two accelerated rehabilitation programs for use with the InSpace device in the treatment of full thickness Massive, Irreparable Rotator Cuff Tears (MIRCTs) performed during an arthroscopic procedure.
Eligibility criteria
Qualifiers
The subject has signed the IRB approved Informed Consent Form (ICF) specific to this study prior to enrollment
Is male or female ≥ sixty-five (65) years of age
Measuring ≥ 5 cm in diameter
Involving ≥ two tendons
Disqualifiers
Known allergy to the device material (copolymer of PLA (poly (lactic acid) and -ε-caprolactone)
Severe gleno-humeral or acromio-humeral arthritis
Full thickness cartilage loss as seen on MRI
History within the past 5 years of anterior or posterior shoulder subluxation or dislocation as determined by history, examination, or radiographic findings
Trial design
Treatments tested in this trial
- InSpace Subacromial Tissue Spacer
Treatment groups
160 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov