Trials Sponsors Conditions Drugs Pricing

Conditions

Arthritis

Outcome Measures

Primary Outcomes (1)

Proportion of Participants with Revision by 10 Years
Proportion of participants with revision by 10 years. A revision was defined as removal with or without replacement of the components (device revision may have been partial or total).
10 years

Secondary Outcomes (16)

Harris Hip Score (HHS): Overall Score
Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Harris Hip Score (HHS): Pain Score
Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Harris Hip Score (HHS): Function Score
Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Harris Hip Score (HHS): Absence of Deformity Score
Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Harris Hip Score (HHS): Range of Motion Score
Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
+11 more secondary outcomes

Study Arms (1)

Hip Resurfacing

Birmingham Hip Resurfacing

Device: Birmingham Hip Resurfacing

Interventions

Birmingham Hip ResurfacingDevice

Hip resurfacing system: single use device for hybrid fixation in patients requiring primary hip resurfacing arthroplasty

Also known as: BHR

Hip Resurfacing

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age21 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

The BHR System is a single use device intended for hybrid fixation: cemented femoral head component and cementless acetabular component. The BHR System is intended for use in patients requiring primary hip resurfacing arthroplasty due to: * Non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH, or * Inflammatory arthritis such as rheumatoid arthritis. BHR System is intended for patients who, due to relatively younger age or increase activity level, may not be suitable for traditional total hip arthroplasty due to an increase possibility of requiring future ipsilateral hip joint revision.

You may qualify if:

Sponsors & Collaborators

Smith & Nephew, Inc.
Industrylead

Study Sites (7)

Tucson Orthopaedic Institute

Tucson, Arizona, 85713, United States

Center for Orthopaedics

Lake Charles, Louisiana, 70601, United States

Hospital for Special Surgery

New York, New York, 10021, United States

University of Rochester Medical Center

Rochester, New York, 14672, United States

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Anderson Orthopaedic Clinic

Alexandria, Virginia, 22306, United States

Aurora Medical Center

Grafton, Wisconsin, 53024, United States

Biospecimen

Retention: SAMPLES WITH DNA

laboratory collection: whole blood, serum

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

Andy Engh, MD
Anderson Orthopaedic Clinic
PRINCIPAL INVESTIGATOR
Lawrence Housman, MD
Tucson Orthopaedic Institute
PRINCIPAL INVESTIGATOR
John Masonis, MD
OrthoCarolina Research Institute, Inc.
PRINCIPAL INVESTIGATOR
Edwin Su, MD
Hospital for Special Surgery, New York
PRINCIPAL INVESTIGATOR

Enrollment

329 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 11, 2008

Study Start

October 6, 2006

Actual (reported)

A Safety and Efficacy Study of the Birmingham Hip Resurfacing System

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (16)

Study Arms (1)

Hip Resurfacing

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (16)

Study Arms (1)

Hip Resurfacing

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations