Clinical trial NCT02029469: Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study
Official title: Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Shoulder Arthritis Osteoarthritis
Rheumatoid Arthritis Shoulder
Acquired Deformity of Head
Post-traumatic Arthrosis of Other Joints, Shoulder Region
Keywords: Humeral Resurfacing
Humeral Resurfacing Arthroplasty
Lead sponsor: Ascension Orthopedics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-08
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is a non-randomized, consecutive enrollment, 10-year follow-up study of patients who are treated with the Ascension® HRA. Its purpose is to measure and document the outcomes associated with implanting the Ascension HRA prosthesis. Patients will be periodically assessed to collect data related to safety and effectiveness endpoints at the following intervals: preoperative, surgery/immediate post-op, 3 months, 6 months, 1 year, 2 year, 5 year, and 10 years.

Detailed description: At each assessment interval, information on complications and adverse events will be collected. In addition, shoulder joint range of motion will be collected, and implants will be evaluated radiographically to determine joint position and assess implant with regards to radiolucencies, subsidence and subluxation (migration). Patient satisfaction with regard to the effect of the implant on shoulder function, joint pain, and overall satisfaction will be assessed using a visual analog scale (VAS). Furthermore, if there are any implant revisions during the 10-year follow-up for any of the patients enrolled in the study, the implant and/or surrounding tissue will be harvested if possible and submitted for histopathological examination.

Eligibility criteria: Inclusion Criteria:

* The following patient will be included in the study - Patient who:

  * Is treated with the Ascension HRA;
  * Is disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, osteoarthritis and avascular necrosis;
  * Has mild or moderate humeral head deformity and /or limited motion;
  * Has post-traumatic arthritis;
  * Has an intact or reparable rotator cuff;
  * Has the means and ability to return for all required study visits
  * Is willing to participate in the study;
  * Has signed an Informed Consent Form;
  * Is at least 18 years of age and skeletally mature at the time of surgery;
  * Is less than 75 years of age at the time of surgery

Exclusion Criteria:

The following patients will be excluded from the study - Patients who:

* Infection, sepsis, and osteomyelitis;
* Osteoporosis;
* Metabolic disorders which may impair bone formation;
* Osteomalacia;
* Rapid joint destruction, marked bone loss or bone resorption apparent on X-ray;
* Revision procedures where other devices or treatments have failed
* Refuses to be in the study; or does not have the means and ability to return for all required study visits;
* Currently participating in another clinical study.

Primary outcomes:
measure: American Shoulder and Elbow Surgeon Score
timeFrame: Outcome data will be evaluated at 2 years
Secondary outcomes:
measure: Range of Motion
timeFrame: 2 years
measure: VAS scale for pain
timeFrame: 2 years
measure: AP and axillary radiographs
timeFrame: 2 years
measure: Adverse events
timeFrame: 2 years and during entire trial
Other outcomes:
Locations:
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System
state: Florida
Study officials:
affiliation: Bay Pines VA Health Care System
name: Sam Hakki, M.D.
role: PRINCIPAL_INVESTIGATOR
References: