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

Pain Clinical Trial

Official title:

Fiber Metal Taper Prospective Randomized Weight Bearing Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00179088
• Other study ID #: VUMC IRB#030167
• Secondary ID: Weight Bearing a
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: March 29, 2017
• Start date: May 2003
• Est. completion date: November 2007

Study information

• Verified date: March 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Pain

Intervention

Behavioral:
• Patient may be able to put weight on the operated leg

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To learn if clinical and radiographic outcomes differ in two groups of patients after THA.
Secondary	Femoral Stem Subsidence on X-rays at select post-op times.
Secondary	Return to work status by two years post-operative.
Secondary	Patient is or is not able to walk without assistive device.
Secondary	Joint range of motion.
Secondary	Presence or absence of pain.
Secondary	Severity of pain if present.