NCT00261040

Brief Summary

The purpose of this study is to determine if there is a difference in terms of length of hospital stay and post-operative outcomes between patients whose total hip replacement surgery is performed with a minimally invasive versus standard surgical approach.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2003

Longer than P75 for not_applicable

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

June 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2005

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
8.9 years until next milestone

Results Posted

Study results publicly available

March 27, 2020

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

7.5 years

First QC Date

November 30, 2005

Results QC Date

September 26, 2017

Last Update Submit

March 25, 2020

Conditions

Keywords

OsteoarthritisTotal Hip ArthroplastyMinimally Invasive Surgery

Outcome Measures

Primary Outcomes (1)

  • Clinical Outcomes

    Hospital length of stay

    24 months

Secondary Outcomes (4)

  • Harris Hip Score

    24 months

  • Change in Timed Get-up-and-Go Test (TUG)

    3 months

  • Operating Time Duration

    Day of Surgery

  • Estimated Blood Loss

    Day of surgery

Study Arms (2)

Minimally Invasive Surgery (MIS)

ACTIVE COMPARATOR

In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her.

Procedure: Minimally Invasive Surgery

Standard Surgery

SHAM COMPARATOR

The standard way an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision

Procedure: Standard Surgery

Interventions

In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her.

Minimally Invasive Surgery (MIS)

The standard way that an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision.

Also known as: non applicable
Standard Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \> 30 kg/m2 No prior ipsilateral hip surgery Osteoarthritis

You may not qualify if:

  • Patients with grossly distorted bony anatomy whereby standard implants are contraindicated; i.e. congenital dysplasia of the hip, proximal femoral abnormalities, etc
  • Rheumatoid Arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Interventions

Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Results Point of Contact

Title
Dr Paul Kim
Organization
The Ottawa Hospital - Ottawa Hospital Research Institute

Study Officials

  • Paul Kim, MD

    OHRI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

November 30, 2005

First Posted

December 2, 2005

Study Start

June 1, 2003

Primary Completion

December 1, 2010

Study Completion

May 1, 2011

Last Updated

March 27, 2020

Results First Posted

March 27, 2020

Record last verified: 2020-03