Ascension® Humeral Resurfacing Arthroplasty (HRA) Follow-... | NCT02369497

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

NCT02369497

Sponsor

Integra LifeSciences Corporation

Status

Terminated

Last Update Posted

Feb 24, 2015Estimated

Enrollment

59Actual

Phase

Not provided

Conditions

Arthritis

Interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI left institution and site did not have resources to continue study

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Nov 4, 2014

First Submission Date that Met QC Criteria

Feb 17, 2015

First Posted Date

Feb 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2015

Last Update Posted Date

Feb 24, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Label	Type	Description	Intervention Names
Primary cohort		Primary cohort of subjects who receive the HRA device.	Device: HRA

Name	Type	Description	Arm Group Labels	Other Names
HRA	Device	Humeral head resurfacing with the HRA device	Primary cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Range of Motion	Assessment of range of motion in the shoulder	2 years
Visual Analog Scale for pain	Patient assessed score of pain in the shoulder

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with arthritis requiring humeral resurfacing arthroplasty

Sampling Method

Non-Probability Sample

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases