OsteoarthritisNCT00179088
Safety of Non-delayed Weight Bearing After Total Hip Replacement With Non-Cemented Fiber Metal Taper Stem
A study testing Patient may be able to put weight on the operated leg in people with Osteoarthritis and Pain, run by Vanderbilt University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Pain
- What is being tested?
- Patient may be able to put weight on the operated leg
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Nov 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 or older
- English Speaking
- any form of hip arthritis
- primary total hip arthroplasty
- willing to sign informed consent
Who cannot join
- 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
Show all 9Show fewer
- intra-operative fracture
- prisoners
- not willing to sign informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8774
About this study
Official title: Fiber Metal Taper Prospective Randomized Weight Bearing Investigation
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.
Read the 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
- Being tested
- Patient may be able to put weight on the operated leg
- Keywords
- Weight-Bearing, Total Hip Replacement, Non-cemented, Randomized, Fiber-Metal-Taper-Stem, Hip, Osteoarthritis
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient may be able to put weight on the operated legBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Severity of pain if present.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2003
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- Andrew A. Shinar, M.D., Principal investigator, Vanderbilt University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179088
- Sponsor's protocol ID
- VUMC IRB#030167
- Other IDs
- Weight Bearing after THA
- Status last verified
- Mar 2017
- First submitted
- 13 Sep 2005
- Last updated
- 31 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fiber Metal Taper Prospective Randomized Weight Bearing Investigation
- ClinicalTrials.gov ID
- NCT00179088
- Acronym / sponsor ID
- VUMC IRB#030167
- Conditions
- Osteoarthritis, Pain
- Keywords
- Weight-Bearing, Total Hip Replacement, Non-cemented, Randomized, Fiber-Metal-Taper-Stem, Hip, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- May 2003
- Study completion
- Nov 2007 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18 or older
- English Speaking
- any form of hip arthritis
- primary total hip arthroplasty
- willing to sign informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient may be able to put weight on the operated leg | Behavioural | – |
Primary outcome
To learn if clinical and radiographic outcomes differ in two groups of patients after THA.
6 secondary outcomes
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.
Severity of pain if present.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew A. Shinar, M.D. principal investigator
Vanderbilt University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient may be able to put weight on the operated leg in people with Osteoarthritis and Pain, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To learn if clinical and radiographic outcomes differ in two groups of patients after THA.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.