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Safety of Non-delayed Weight Bearing After Total Hip Replacement With Non-Cemented Fiber Metal Taper Stem

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00179088
First Posted: September 15, 2005
Last Update Posted: March 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
Vanderbilt University Medical Center
  Purpose
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.

Condition Intervention
Osteoarthritis Pain Behavioral: Patient may be able to put weight on the operated leg

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fiber Metal Taper Prospective Randomized Weight Bearing Investigation

Resource links provided by NLM:


Further study details as provided by Vanderbilt University Medical Center:

Primary Outcome Measures:
  • To learn if clinical and radiographic outcomes differ in two groups of patients after THA.

Secondary Outcome Measures:
  • 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.
  • Presence or absence of pain.
  • Severity of pain if present.

Estimated Enrollment: 33
Study Start Date: May 2003
Study Completion Date: November 2007
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179088


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-8774
Sponsors and Collaborators
Vanderbilt University Medical Center
Zimmer Biomet
Investigators
Principal Investigator: Andrew A. Shinar, M.D. Vanderbilt University School of Medicine
  More Information

Responsible Party: Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00179088     History of Changes
Other Study ID Numbers: VUMC IRB#030167
Weight Bearing after THA
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: March 31, 2017
Last Verified: March 2017

Keywords provided by Vanderbilt University Medical Center:
Weight-Bearing
Total Hip Replacement
Non-cemented
Randomized
Fiber-Metal-Taper-Stem
Hip
Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases