Humeral Resurfacing Hemiarthroplasty

Humeral Resurfacing Hemiarthroplasty. Phase 2: Prospective Cohort Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00477360

Acronym

CAP

Enrollment

Registered

2007-05-23

Start date

2007-01-31

Completion date

2013-02-28

Last updated

2011-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Glenohumeral Arthritis

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.

Interventions

DEVICEHumeral surface replacement hemiarthroplasty (CAP)

C.A.P hemiarthroplasty

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
American Shoulder And Elbow Surgeons Shoulder Index (ASES)	24 months post-operative

Secondary

Measure	Time frame
Constant Score	24 months post-operative
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)	24 months post-operative
Simple Shoulder Test (SST)	24 months post-operative
Radiographic Evaluation	3 months + yearly post-operative

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026