Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study

Rheumatoid Arthritis Shoulder Clinical Trial

Official title:

Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02029469
• Other study ID #: CP- HRA-001
• Status: Terminated
• Phase: N/A
• First received: April 25, 2012
• Last updated: August 15, 2014
• Start date: October 2007
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Ascension Orthopedics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Deformity of Head
• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Post-traumatic Arthrosis of Other Joints, Shoulder Region
• Rheumatoid Arthritis Shoulder
• Shoulder Arthritis Osteoarthritis

Intervention

Device:
• Ascension HRA device
Patients who are treated with the Ascension® HRA for resurfacing of humeral head.

Locations

Country	Name	City	State
United States	Bay Pines VA Healthcare System	Bay Pines	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ascension Orthopedics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Shoulder and Elbow Surgeon Score	The ASES score will be evaluated at 2 years and compared to baseline.	Outcome data will be evaluated at 2 years	No
Secondary	Range of Motion	Shoulder range of motion will be measured compared to baseline.	2 years	No
Secondary	VAS scale for pain	VAS score for pain will be evaluated at 2 years and compared to baseline.	2 years	No
Secondary	AP and axillary radiographs	Radiographs will be evaluated at 2 years for subsidence, lucent lines and evidence of movement or pending failure.	2 years	Yes
Secondary	Adverse events	AEs will be assessed at each study timepoint	2 years and during entire trial	Yes