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

NCT00179088 | Completed

• 2 other identifiers: VUMC IRB#030167Weight Bearing after THA
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Pain

Keywords

Weight-Bearing; Total Hip Replacement; Non-cemented; Randomized; Fiber-Metal-Taper-Stem; Hip; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

• 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.

Interventions

Patient may be able to put weight on the operated leg BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 or older
• English Speaking
• any form of hip arthritis
• primary total hip arthroplasty
• willing to sign informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-8774, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew A. Shinar, M.D.

  Vanderbilt University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: May 1, 2003
• Study Completion: November 1, 2007
• Last Updated: March 31, 2017

Record last verified: 2017-03

Locations

US (1)