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Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study

Primary Purpose

Shoulder Arthritis Osteoarthritis, Rheumatoid Arthritis Shoulder, Acquired Deformity of Head

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ascension HRA device
Sponsored by
Ascension Orthopedics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Arthritis Osteoarthritis focused on measuring Humeral Resurfacing, Humeral Resurfacing Arthroplasty

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bay Pines VA Healthcare System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HRA Device

Arm Description

Patients who will be treated with Ascension HRA device.

Outcomes

Primary Outcome Measures

American Shoulder and Elbow Surgeon Score
The ASES score will be evaluated at 2 years and compared to baseline.

Secondary Outcome Measures

Range of Motion
Shoulder range of motion will be measured compared to baseline.
VAS scale for pain
VAS score for pain will be evaluated at 2 years and compared to baseline.
AP and axillary radiographs
Radiographs will be evaluated at 2 years for subsidence, lucent lines and evidence of movement or pending failure.
Adverse events
AEs will be assessed at each study timepoint

Full Information

First Posted
April 25, 2012
Last Updated
August 15, 2014
Sponsor
Ascension Orthopedics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02029469
Brief Title
Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study
Official Title
Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to PI leaving the institution
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ascension Orthopedics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Arthritis Osteoarthritis, Rheumatoid Arthritis Shoulder, Acquired Deformity of Head, Post-traumatic Arthrosis of Other Joints, Shoulder Region
Keywords
Humeral Resurfacing, Humeral Resurfacing Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HRA Device
Arm Type
Experimental
Arm Description
Patients who will be treated with Ascension HRA device.
Intervention Type
Device
Intervention Name(s)
Ascension HRA device
Other Intervention Name(s)
Ascension Metal HRA device
Intervention Description
Patients who are treated with the Ascension® HRA for resurfacing of humeral head.
Primary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeon Score
Description
The ASES score will be evaluated at 2 years and compared to baseline.
Time Frame
Outcome data will be evaluated at 2 years
Secondary Outcome Measure Information:
Title
Range of Motion
Description
Shoulder range of motion will be measured compared to baseline.
Time Frame
2 years
Title
VAS scale for pain
Description
VAS score for pain will be evaluated at 2 years and compared to baseline.
Time Frame
2 years
Title
AP and axillary radiographs
Description
Radiographs will be evaluated at 2 years for subsidence, lucent lines and evidence of movement or pending failure.
Time Frame
2 years
Title
Adverse events
Description
AEs will be assessed at each study timepoint
Time Frame
2 years and during entire trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Hakki, M.D.
Organizational Affiliation
Bay Pines VA Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bay Pines VA Healthcare System
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States

12. IPD Sharing Statement

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