Clinical trial NCT00179088: Safety of Non-delayed Weight Bearing After Total Hip Replacement With Non-Cemented Fiber Metal Taper Stem
Official title: Fiber Metal Taper Prospective Randomized Weight Bearing Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Pain
Keywords: Weight-Bearing
Total Hip Replacement
Non-cemented
Randomized
Fiber-Metal-Taper-Stem
Hip
Osteoarthritis
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2005-09-15
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To learn if clinical and radiographic outcomes differ in two groups of patients after THA.
Secondary outcomes:
measure: Femoral Stem Subsidence on X-rays at select post-op times.
measure: Return to work status by two years post-operative.
measure: Patient is or is not able to walk without assistive device.
measure: Joint range of motion.
measure: Presence or absence of pain.
measure: Severity of pain if present.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University School of Medicine
name: Andrew A. Shinar, M.D.
role: PRINCIPAL_INVESTIGATOR
References: