Clinical trial NCT02369497: Ascension® Humeral Resurfacing Arthroplasty (HRA) Follow-Up Study
Official title: Ascension® Humeral Resurfacing Arthroplasty HRA Follow-Up Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arthritis
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2015-02-24
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with arthritis requiring humeral resurfacing arthroplasty

Brief summary: This is a prospective study on the Ascension HRA device to collect data to assess the safety and effectiveness of the HRA.

Detailed description: This study protocol will provide guidance to investigators wanting to perform 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.

Eligibility criteria: Inclusion Criteria:

Any patient who is to be treated with the Ascension HRA is eligible for inclusion in this study. Therefore, Principal Investigators should attempt to recruit all patients at the study site who are treated with the Ascension HRA

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:

* 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 Surgeons (ASES) Score
timeFrame: 2 years
Secondary outcomes:
measure: Range of Motion
timeFrame: 2 years
measure: Visual Analog Scale for pain
timeFrame: 2 years
measure: X-rays
timeFrame: 2 years
measure: Adverse events
timeFrame: Surgery; 3 month, 6 month, 1 year and 2 years post-op
Other outcomes:
Locations:
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System
state: Florida
Study officials:
affiliation: Integra LifeSciences
name: Candi Langmaid, MPH, CCRP
role: STUDY_DIRECTOR
References: