NCT00750984

Brief Summary

This study compares the posterior approach to the anterolateral approach using the ReCap® Total Hip Resurfacing System.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

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

September 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 11, 2018

Status Verified

September 1, 2016

Enrollment Period

4.8 years

First QC Date

September 10, 2008

Last Update Submit

January 9, 2018

Conditions

ArthritisAvascular Necrosis

Outcome Measures

Primary Outcomes (1)

  • RSA

    1 week, 3 months, 1 year, 2 years, 5 years

Secondary Outcomes (5)

  • Harris Hip Score

    Pre-operatively, 1 week, 6 weeks, 3 months, 1 year

  • Microdialysis

    1 week

  • Conventional X-ray

    1 week

  • Gait Analysis

    1 week, 3 months, 1 year

  • DEXA scan

    Pre-operatively, 1 week, 1 year, 2 years

Study Arms (2)

1

EXPERIMENTAL

This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.

Procedure: Anterolateral approachDevice: ReCap Total Hip Resurfacing

2

ACTIVE COMPARATOR

This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.

Procedure: Posterior approachDevice: ReCap Total Hip Resurfacing

Interventions

Anterolateral approachPROCEDURE

The anterolateral approach is performed with the patient positioned on the side. The blood supply to the femoral neck from the medial circumflex artery is regarded preserved by this surgical method.

1
Posterior approachPROCEDURE

The posterior approach is performed with the patient positioned on the side. The medial circumflex artery is cut at the lower border of the short external rotators risking a compromised blood supply to the femoral head.

2
ReCap Total Hip ResurfacingDEVICE

This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.

1

Eligibility Criteria

Age29 Years - 61 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primary hip OA
  • Secondary hip OA due to mild and moderate acetabular dysplasia
  • Sufficient bone quality for cementless acetabular component
  • Suited for resurfacing of the femoral head (pre- and intraoperatively assessed)
  • \>29 years
  • \<61 years

You may not qualify if:

  • Neuromuscular or vascular diseases in affected leg
  • Patients found intra-operatively to be unsuited for a cementless acetabular component or cementing of the femoral component
  • Need of NSAID post-operatively
  • Fracture sequelae
  • Females at risk of pregnancy (no safe contraceptives)
  • Severe hip dysplasia
  • Sequelae from hip disease in childhood
  • Medicine with large effect on bone density (K-vitamin antagonists, loop-diuretic)
  • Alcoholism (females \> 14 units per week, males \> 21 units per week) AVN
  • Osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Denmark

Location

MeSH Terms

Conditions

ArthritisOsteonecrosis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Pryno, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Kjeld Soeballe, MD, PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2008

First Posted

September 11, 2008

Study Start

September 1, 2008

Primary Completion

July 1, 2013

Study Completion

February 1, 2017

Last Updated

January 11, 2018

Record last verified: 2016-09

Locations

DK(1)