Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HRA Device Patients who will be treated with Ascension HRA device. |
Device: Ascension HRA device
Patients who are treated with the Ascension® HRA for resurfacing of humeral head.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- American Shoulder and Elbow Surgeon Score [Outcome data will be evaluated at 2 years]
The ASES score will be evaluated at 2 years and compared to baseline.
Secondary Outcome Measures
- Range of Motion [2 years]
Shoulder range of motion will be measured compared to baseline.
- VAS scale for pain [2 years]
VAS score for pain will be evaluated at 2 years and compared to baseline.
- AP and axillary radiographs [2 years]
Radiographs will be evaluated at 2 years for subsidence, lucent lines and evidence of movement or pending failure.
- Adverse events [2 years and during entire trial]
AEs will be assessed at each study timepoint
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bay Pines VA Healthcare System | Bay Pines | Florida | United States | 33744 |
Sponsors and Collaborators
- Ascension Orthopedics, Inc.
Investigators
- Principal Investigator: Sam Hakki, M.D., Bay Pines VA Health Care System
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP- HRA-001