Ascension® Humeral Resurfacing Arthroplasty (HRA) Follow-Up Study

Arthritis Clinical Trial

— HRA  

Official title:

Ascension® Humeral Resurfacing Arthroplasty HRA Follow-Up Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02369497
• Other study ID #: CP-HRA-001
• Status: Terminated
• Phase: N/A
• First received: November 4, 2014
• Last updated: February 17, 2015
• Start date: December 2007
• Est. completion date: July 2014

Study information

• Verified date: February 2015
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

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:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis

Intervention

Device:
• HRA
Humeral head resurfacing with the HRA device

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Shoulder and Elbow Surgeons (ASES) Score	The American Shoulder and Elbow Score is a functional outcome tool that has been validated for various shoulder conditions	2 years	No
Secondary	Range of Motion	Assessment of range of motion in the shoulder	2 years	No
Secondary	Visual Analog Scale for pain	Patient assessed score of pain in the shoulder	2 years	No
Secondary	X-rays	X-rays are conducted to assess the location and placement of the HRA device in the shoulder	2 years	No
Secondary	Adverse events	assessment of any adverse events that occur during the trial	Surgery; 3 month, 6 month, 1 year and 2 years post-op	Yes