Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study

Not Applicable

Terminated

• Conditions: Shoulder Arthritis Osteoarthritis; Post-traumatic Arthrosis of Other Joints, Shoulder Region; Rheumatoid Arthritis Shoulder; Acquired Deformity of Head
• Interventions: Device: Ascension HRA device

• Registration Number: NCT02029469
• Lead Sponsor: Ascension Orthopedics, Inc.

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-08
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-15
• Last Update Posted: 2014-08-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HRA Device	Ascension HRA device	Patients who will be treated with Ascension HRA device.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
AP and axillary radiographs	2 years	Radiographs will be evaluated at 2 years for subsidence, lucent lines and evidence of movement or pending failure.
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.
Adverse events	2 years and during entire trial	AEs will be assessed at each study timepoint

Trial Locations

Locations (1)

Bay Pines VA Healthcare System; 🇺🇸 Bay Pines, Florida, United States