Clinical trial NCT03858517: A Post-Market Clinical Evaluation of the ReUnion TSA System
Official title: A Post-Market Clinical Evaluation of the ReUnion TSA System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Shoulder Arthroplasty
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2019-02-28
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 subjects are to be enrolled in this clinical investigation. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty subjects, which entails clinical evaluation on a regular ongoing basis, or as needed should the subject become symptomatic in the treated joint.

Brief summary: This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 4-7 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty subjects, which entails clinical evaluation on a regular ongoing basis, or as needed should the subject become symptomatic in the treated joint.

Detailed description: The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the ReUnion TSA System. Efficacy/performance of the procedure will be measured the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Safety of the ReUnion TSA System will be demonstrated through reporting of device-related intra-operative and post-operative Adverse Events (AEs). Enrolled subjects will be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6 Months, 12 Months, 24 Months and annually thereafter up to 10 years following the index procedure.

Eligibility criteria: Inclusion Criteria:

* Subject is willing to sign the informed consent.
* Subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
* Subject is male or non-pregnant female and 18 years or older at the time of surgery.
* Subject has one or more of the following:

  * Aseptic necrosis of the humeral head
  * Painful, disabling joint disease of the shoulder resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis
  * Failed previous total shoulder replacement, resurfacing or other procedure

Exclusion Criteria:

* Subject has an active or suspected latent infection in or about the shoulder joint.
* Subject has mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care.
* Subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
* Subject has anticipated activities which would impose high stresses on the prosthesis and its fixation.
* Subject is obese such that he/she produces a load on the prosthesis which can lead to failure of fixation of the device or to failure of the device itself.
* Subject has absent, irreparable or non-functioning rotator cuff and other essential muscles.
* Subject has concomitant disease(s) which may significantly affect the clinical outcome.
* Subject has traumatic or pathologic fracture of the proximal humerus.

Primary outcomes:
measure: American Shoulder and Elbow Surgeons (ASES) Shoulder Score
timeFrame: 24 months
Secondary outcomes:
measure: Safety Will be Measured by Capturing the Incidence Rate of Device-related Intra-operative and Post-operative Adverse Events Will be Measured.
timeFrame: 24 mths
measure: Efficacy Will be Measured by Monitoring All Implant Survivorship in All Subjects Who Have the Total or Partial Prosthesis With Full or Partial Implant Survival.
timeFrame: From Baseline to last recorded follow-up (~27 Months)
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Great Plains Orthopedics
state: Illinois
city: Nashville
country: United States
facility: Tennessee Orthopaedic Alliance
state: Michigan
city: Greenville
country: United States
facility: Steadman Hawkins Clinic of the Carolinas
state: South Carolina
Study officials:
affiliation: Stryker Trauma
name: Rebecca Gibson
role: STUDY_DIRECTOR
References: