- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00179088
Safety of Non-delayed Weight Bearing After Total Hip Replacement With Non-Cemented Fiber Metal Taper Stem
March 29, 2017 updated by: Vanderbilt University Medical Center
Fiber Metal Taper Prospective Randomized Weight Bearing Investigation
The purpose of this study is to determine if full weight bearing following total hip replacement can speed recovery when the hip replacement in the long bone of the leg is not cemented into the bone.
When cement is used, most surgeons allow full or nearly full weight bearing following hip replacement.
One drawback to cementless implants has been the restriction of weight bearing for six to eight weeks after surgery, during which time patients are allowed to only put their foot flat on the floor of the operated leg without bearing weight on that leg.
This study compares the effect of immediate weight bearing on the speed of recovery from hip replacement surgery in two groups of patients receiving a non-cemented total hip replacement: one group is randomly assigned to not bear weight, and the other group is randomly assigned to allowed, tolerated weight bearing from the day of surgery forward.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients undergoing non-cemented total hip arthroplasty with a Zimmer Fiber Metal Taper Stem and who meet the inclusion and exclusion criteria are offered the informed consent process.
Those consenting are randomized following surgery by flip of a coin into one of two groups: Weight Bearing as Tolerated or Toe Touch Weight Bearing Only.
Each patient is followed for two years, and is seen at 6 weeks, 3 months, 1 year and two years.
Questionnaires are completed including the Harris Hip Score and the SF-36.
Patients complete a compliance survey to determine behavior related to their study group assignment and compliance with their study group.
Radiographs are obtained at each post-operative interval and subsidence is evaluated and recorded.
Range of motion and ambulation are assessed and recorded also.
Study Type
Interventional
Enrollment
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232-8774
- Vanderbilt University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 18 or older
- English Speaking
- any form of hip arthritis
- primary total hip arthroplasty
- willing to sign informed consent
Exclusion Criteria:
- under age 18
- non-English speaking
- critically ill patients
- people who are unable to follow-up appropriately due to travel concerns or mental illness.
- revision total hip arthroplasty
- trochanteric osteotomy
- intra-operative fracture
- prisoners
- not willing to sign informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
To learn if clinical and radiographic outcomes differ in two groups of patients after THA.
|
Secondary Outcome Measures
Outcome Measure |
---|
Femoral Stem Subsidence on X-rays at select post-op times.
|
Return to work status by two years post-operative.
|
Patient is or is not able to walk without assistive device.
|
Joint range of motion.
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Presence or absence of pain.
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Severity of pain if present.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Andrew A. Shinar, M.D., Vanderbilt University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2003
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Actual)
March 31, 2017
Last Update Submitted That Met QC Criteria
March 29, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VUMC IRB#030167
- Weight Bearing after THA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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