NCT00405483

Brief Summary

The purpose of this study is to determine if MIS for primary hip replacement surgery increases the risk of long term aseptic loosening as predicted by implant micromotion detected by radiostereometric analysis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2006

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 8, 2019

Status Verified

January 1, 2019

Enrollment Period

9.2 years

First QC Date

November 28, 2006

Last Update Submit

February 7, 2019

Conditions

Osteoarthritis

Keywords

arthroplastyRSAmicromotionosteoarthritisminimally invasiveProfemurZ

Outcome Measures

Primary Outcomes (1)

  • The purpose of this study is to determine if MIS for primary hip replacement surgery increases the risk of long term aseptic loosening as predicted by implant micromotion detected by radiostereometric analysis

    2 years

Study Arms (2)

Minimally invasive exposure

ACTIVE COMPARATOR

Surgical technique, minimal incision

Procedure: Minimally Invasive

Standard exposure

ACTIVE COMPARATOR

Standard Incision

Procedure: Standard exposure

Interventions

Standard exposurePROCEDURE

Minimal invasive vs standard exposure of the joint is the difference between a small incision, smaller equipment for less tissue damage vs large incision (standard is greater than 10cm)and subsequent more tissue damage.

Also known as: Surgical technique, standard exposure in hip arthroplasty
Standard exposure
Minimally InvasivePROCEDURE

Minimally invasive surgical technique (minimal incision)

Minimally invasive exposure

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects are under the age of 65 years
  • Subjects have not had hip replacement surgery on the affected hip
  • Subjects have decided to undergo a primary total hip replacement of the affected hip

You may not qualify if:

  • Having a previous hip infection
  • Undergoing surgery for arthritis due to a previous injury, rheumatoid arthritis or hip dysplasia (a hip that did not develop completely)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Michael Gross, MD FRCSC

    Dalhousie University & Capital District Health Authority

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2006

First Posted

November 30, 2006

Study Start

October 1, 2005

Primary Completion

December 1, 2014

Study Completion

December 1, 2019

Last Updated

February 8, 2019

Record last verified: 2019-01

Locations

CA(1)