CClinicalTrials.gg
Status unknownNCT00477360CAPUpdated Aug 11, 2011

Humeral Resurfacing Hemiarthroplasty

An interventional study of Humeral surface replacement hemiarthroplasty (CAP) in Advanced Glenohumeral Arthritis, sponsored by University of Calgary. Status unknown at 1 site in Canada. Per ClinicalTrials.gov, last updated 2011-08-11.

Sponsored by University of Calgary · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2011), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Sex
All
01

Study summary

The primary objective of this study is to examine quality of life outcomes in patients who have undergone a humeral surface replacement hemiarthroplasty.

Read the 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.

02

Conditions studied

  • Advanced Glenohumeral Arthritis

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03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 30 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    1

    C.A.P

    Device: Humeral surface replacement hemiarthroplasty (CAP)

Interventions

  • DeviceHumeral surface replacement hemiarthroplasty (CAP)

    C.A.P hemiarthroplasty

06

What researchers measure

Primary outcomes

  1. American Shoulder And Elbow Surgeons Shoulder Index (ASES)

    Time frame: 24 months post-operative

Secondary outcomes

  1. Constant Score

    Time frame: 24 months post-operative

  2. Western Ontario Osteoarthritis of the Shoulder Index (WOOS)

    Time frame: 24 months post-operative

  3. Simple Shoulder Test (SST)

    Time frame: 24 months post-operative

  4. Radiographic Evaluation

    Time frame: 3 months + yearly post-operative

07

Study locations

1 site
  • University of Calgary Sport Medicine Centre
    Calgary, Alberta T2N 1N4, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00477360
Lead sponsor
University of Calgary
Collaborators
DePuy International, Johnson & Johnson
First posted
May 23, 2007
Start date
Jan 2007
Primary completion
Feb 2013 (estimated)
Completion
Feb 2013 (estimated)
Last update
Aug 11, 2011

Study contacts

Dr. Richard Boorman
principal investigator · University of Calgary
Dr. Dianne Bryant
principal investigator · Western University, Canada

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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