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

This study has been completed.
Sponsor:
Collaborator:
Zimmer, Inc.
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00179088
First received: September 13, 2005
Last updated: November 1, 2010
Last verified: November 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

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
Estimated Study Completion Date: December 2006
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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179088

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

No publications provided

ClinicalTrials.gov Identifier: NCT00179088     History of Changes
Other Study ID Numbers: VUMC IRB#030167, Weight Bearing after THA
Study First Received: September 13, 2005
Last Updated: November 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
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

ClinicalTrials.gov processed this record on October 23, 2014