Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study | NCT02029469

Studies
Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study

NCT02029469

Sponsor

Ascension Orthopedics, Inc.

Status

Terminated

Last Update Posted

Aug 18, 2014Estimated

Enrollment

59Actual

Phase

Not Applicable

Conditions

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

Interventions

Ascension HRA device

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

Aug 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was terminated due to PI leaving the institution

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Apr 25, 2012

First Submission Date that Met QC Criteria

Jan 6, 2014

First Posted Date

Jan 8, 2014Estimated

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

Aug 15, 2014

Last Update Posted Date

Aug 18, 2014Estimated

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HRA Device	Experimental	Patients who will be treated with Ascension HRA device.	Device: Ascension HRA device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ascension HRA device	Device	Patients who are treated with the Ascension® HRA for resurfacing of humeral head.	HRA Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Range of Motion	Shoulder range of motion will be measured compared to baseline.	2 years
VAS scale for pain	VAS score for pain will be evaluated at 2 years and compared to baseline.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

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

Not provided

Sampling Method

Not provided