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

NCT ID: NCT00179088

Last Updated: 2017-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2007-11-30

Brief Summary

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.

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.

Conditions

Osteoarthritis; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Patient may be able to put weight on the operated leg

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew A. Shinar, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University School of Medicine

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

Weight Bearing after THA

Identifier Type: -

Identifier Source: secondary_id

VUMC IRB#030167

Identifier Type: -

Identifier Source: org_study_id