NCT00116948

Brief Summary

The purpose of this study is to compare two total hip replacement systems: Hip Resurfacing System (ReCap) versus Mallory-Head/Exeter.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_4

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

January 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2005

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

6.7 years

First QC Date

June 30, 2005

Last Update Submit

December 3, 2014

Conditions

Osteoarthrosis

Keywords

OsteoarthrosisRSADEXAHip arthroplastyMetal ionInflammatory responseGait analysis

Outcome Measures

Primary Outcomes (5)

  • Metal ion release evaluated in urine

    three years

  • Gait pattern evaluated with 3D gait analysis, Vicon Polygon

    two years

  • Bone mineral density (BMD) in surrounding bone of the prosthesis

    three years

  • Prostheses migration evaluated by radiostereometric analysis (RSA)

    three years

  • Proinflammatory- and bone degradation measures in blood samples

    three years

Interventions

ReCap, Hip resurfacing system, BiometDEVICE

ReCap total hip arthroplasty inserted according to manufactures manual.

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with primary hip osteoarthrosis (OA).
  • Informed patient consent in writing.
  • Sufficient bone density to allow uncemented implantation of an acetabular component.

You may not qualify if:

  • Presence of other metal implants.
  • Working exposure of chrome, cobalt or molybdenum.
  • Ingestion of multivitamin or medication containing chrome, cobalt or molybdenum.
  • Kidney disease
  • Hip joint dysplasia
  • Patients with neuromuscular or vascular disease in the affected leg.
  • Patients who regularly take non-steroid anti-inflammatory drugs (NSAID) and cannot interrupt intake for the postoperative phase of the study.
  • Patients with fracture sequelae.
  • Female patients of childbearing capacity.
  • Sequelae to previous hip joint disorder in childhood

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Center, Aarhus University Hospital

Aarhus, Jylland, 8000, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kjeld Søballe, MD., Prof.

    Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 1, 2005

Study Start

January 1, 2005

Primary Completion

September 1, 2011

Study Completion

January 1, 2012

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations

DK(1)