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Completed

NCT Number: NCT00179088

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

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-8774, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient may be able to put weight on the operated leg

Behavioral

Primary outcomes

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

Secondary outcomes

  1. Femoral Stem Subsidence on X-rays at select post-op times.

  2. Return to work status by two years post-operative.

  3. Patient is or is not able to walk without assistive device.

  4. Joint range of motion.

  5. Presence or absence of pain.

  6. Severity of pain if present.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Zimmer Biomet

Registry information

Official study title

Fiber Metal Taper Prospective Randomized Weight Bearing Investigation

Important dates

Study start
2003
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
Mar 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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