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Humeral Resurfacing Hemiarthroplasty (CAP)

Primary Purpose

Advanced Glenohumeral Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Humeral surface replacement hemiarthroplasty (CAP)
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Glenohumeral Arthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Pre-Operative Inclusion Criteria:

  • Failed standard non-surgical management (analgesics, nsaids, physiotherapy, activity modification)
  • Persistent pain and disability for at least 6 months
  • Imaging demonstrates advanced humeral head cartilage loss

Pre-Operative Exclusion Criteria:

  • Active or systemic joint infection
  • Significant muscle paralysis of shoulder girdle
  • Charcot's Arthropathy
  • Major medical illness (life expectancy <2years)
  • Unable to speak and read English/French
  • Psychiatric illness that precludes informed consent
  • Unwilling/unable to remain in study for one year

Intra-Operative Inclusion Criteria:

Advanced humeral head cartilage loss AND ONE of:

  • minimal/no glenoid cartilage loss
  • complete glenoid cartilage loss and no bony erosion
  • complete glenoid cartilage loss and concentric bony erosion with no humeral anterior/posterior subluxation

Intra-Operative Exclusion Criteria:

  • Eccentric glenoid erosion with biconcavity of glenoid and subluxation of humeral head
  • Inability of humeral head to support the CAP surface replacement

Sites / Locations

  • University of Calgary Sport Medicine Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

C.A.P

Outcomes

Primary Outcome Measures

American Shoulder And Elbow Surgeons Shoulder Index (ASES)

Secondary Outcome Measures

Constant Score
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
Simple Shoulder Test (SST)
Radiographic Evaluation

Full Information

First Posted
May 22, 2007
Last Updated
August 10, 2011
Sponsor
University of Calgary
Collaborators
DePuy International, Johnson & Johnson
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1. Study Identification

Unique Protocol Identification Number
NCT00477360
Brief Title
Humeral Resurfacing Hemiarthroplasty
Acronym
CAP
Official Title
Humeral Resurfacing Hemiarthroplasty. Phase 2: Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
February 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Calgary
Collaborators
DePuy International, Johnson & Johnson

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to examine quality of life outcomes in patients who have undergone a humeral surface replacement hemiarthroplasty.
Detailed Description
Resurfacing arthroplasty is gaining popularity for the reconstruction of advanced shoulder arthritis. New generation re-surfacing prostheses are engineered to anatomically restore a smooth articulating surface to the humeral head, while preserving bone stock, and potentially minimizing the risk for diaphyseal fracture. The results for shoulder resurfacing prostheses have largely been reported in retrospective reviews and have been very favorable. The purpose of this multi-centered, prospective study will be to determine the extent to which patient self-assessed outcomes (American Shoulder and Elbow Society (ASES) Score) following humeral resurfacing improve compared to pre-operative ASES scores.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Glenohumeral Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
C.A.P
Intervention Type
Device
Intervention Name(s)
Humeral surface replacement hemiarthroplasty (CAP)
Intervention Description
C.A.P hemiarthroplasty
Primary Outcome Measure Information:
Title
American Shoulder And Elbow Surgeons Shoulder Index (ASES)
Time Frame
24 months post-operative
Secondary Outcome Measure Information:
Title
Constant Score
Time Frame
24 months post-operative
Title
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
Time Frame
24 months post-operative
Title
Simple Shoulder Test (SST)
Time Frame
24 months post-operative
Title
Radiographic Evaluation
Time Frame
3 months + yearly post-operative

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Pre-Operative Inclusion Criteria: Failed standard non-surgical management (analgesics, nsaids, physiotherapy, activity modification) Persistent pain and disability for at least 6 months Imaging demonstrates advanced humeral head cartilage loss Pre-Operative Exclusion Criteria: Active or systemic joint infection Significant muscle paralysis of shoulder girdle Charcot's Arthropathy Major medical illness (life expectancy <2years) Unable to speak and read English/French Psychiatric illness that precludes informed consent Unwilling/unable to remain in study for one year Intra-Operative Inclusion Criteria: Advanced humeral head cartilage loss AND ONE of: minimal/no glenoid cartilage loss complete glenoid cartilage loss and no bony erosion complete glenoid cartilage loss and concentric bony erosion with no humeral anterior/posterior subluxation Intra-Operative Exclusion Criteria: Eccentric glenoid erosion with biconcavity of glenoid and subluxation of humeral head Inability of humeral head to support the CAP surface replacement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Richard Boorman
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Dianne Bryant
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary Sport Medicine Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada

12. IPD Sharing Statement

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Humeral Resurfacing Hemiarthroplasty

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