Minimally Invasive Surgery of the Hip Versus Standard Approach
1 other identifier
interventional
40
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2003
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 30, 2005
CompletedFirst Posted
Study publicly available on registry
December 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
March 27, 2020
CompletedMarch 27, 2020
March 1, 2020
7.5 years
November 30, 2005
September 26, 2017
March 25, 2020
Conditions
Keywords
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 COMPARATORIn 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.
Standard Surgery
SHAM COMPARATORThe 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
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.
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.
Eligibility Criteria
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
- Ottawa Hospital Research Institutelead
- Zimmer Biometcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Paul Kim
- Organization
- The Ottawa Hospital - Ottawa Hospital Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Kim, MD
OHRI
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