NCT01359527

Brief Summary

This study compares the change (loss) of bone mineral density (BMD) that occurs in the proximal femur after hip resurfacing and total hip replacement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2011

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

9.9 years

First QC Date

May 22, 2011

Last Update Submit

April 25, 2019

Conditions

Keywords

Total Hip ReplacementHip ResurfacingFemoral RemodelingBone LossBone Mineral DensityBMDDXADEXATHA

Outcome Measures

Primary Outcomes (1)

  • Bone Mineral Density

    To evaluate the bone loss in the proximal femur resulting from hip resurfacing surgery and to compare this to the bone loss in the proximal femur resulting from total hip arthroplasty.

    Baseline, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative

Secondary Outcomes (1)

  • Harris Hip Score

    Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative

Study Arms (2)

Hip Resurfacing

Device: Hip Resurfacing

Total Hip Arthroplasty

Device: Total Hip Arthroplasty

Interventions

Hip Resurfacing
Total Hip Arthroplasty

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing hip replacement or resurfacing for osteoarthritis

You may qualify if:

  • Age of at least 20 years
  • Osteoarthritis
  • Elective Total Hip Arthroplasty / Resurfacing
  • Signed Informed Consent

You may not qualify if:

  • Osteoporosis
  • Revisions
  • Femoral dysplasia
  • Trochanteric osteotomy
  • Inflammatory arthritis
  • Breast-feeding, pregnancy, or women of child-bearing potential without documentation of a negative pregnancy test and not utilizing contraception
  • Patients with a history of having taken or currently taking PTH, fluoride therapy or strontium ranelate or patients taking other chronic medications that in the Investigator's opinion are known to affect bone mineral density in a substantial way
  • Patients with severe medical condition(s) that in the view of the Investigator prohibits participation in the study
  • Use of any other investigational agent in the last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spokane Joint Replacement Center

Spokane, Washington, 99218, United States

Location

MeSH Terms

Conditions

Osteoarthritis, HipBone Diseases, Metabolic

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBone DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • David Scott, MD

    Spokane Joint Replacement Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

May 22, 2011

First Posted

May 24, 2011

Study Start

December 1, 2008

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

April 26, 2019

Record last verified: 2019-04

Locations