Osteoarthritis of HipNCT01668160
Stability of Revision Total Hip Arthroplasty Implants Using Radiostereometric Analysis
A study testing Bead placement during revision hip replacement surgery in people with Osteoarthritis of Hip and Failure of Primary THA, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The specific aim is to quantify the stability of the acetabular and femoral components of a revision total hip arthroplasty (THA) in vivo as currently performed at our institution. In this way, the investigators will gain insight into the outcome of the current state of the art of revision arthroplasty surgery. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of Hip, Failure of Primary THA
- What is being tested?
- Bead placement during revision hip replacement surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jan 2020
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female.
- 25 to 75 years of age.
- Subjects requiring revision total hip replacement.
- Subjects who demonstrate the ability to return to MGH for follow-up for the next five years.
Who cannot join
- Subjects with limited life span.
- Subjects with difficulty in comprehending study protocol for any reason.
- Subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, or any other major medical complication which could substantially reduce longevity, put them at further risk due to immunocompromisation or increase the risk of infection.
- Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.
- A urine HCG will be done in all women of child bearing potential prior to RSA imaging at each follow-up visit. The result will be recorded in the research record.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Analysis of the Stability of Total Hip Arthroplasty Implants Used in Revision Surgery Using Radiostereometric Analysis (RSA)
The specific aim is to quantify the stability of the acetabular and femoral components of a revision total hip arthroplasty (THA) in vivo as currently performed at our institution. In this way, the investigators will gain insight into the outcome of the current state of the art of revision arthroplasty surgery. In the past, acetabular and femoral component stability has been measured using radiostereometric analysis (RSA) and when patients having revision total hip operations were compared to patients undergoing primary total hip operations it was possible to determine differences in stability and this was predictive of the intermediate to long-term performance of the acetabular and femoral reconstruction. The investigators propose to use this established, high resolution technique to assess and compare the stability of the revision implants.
- Conditions
- Osteoarthritis of Hip, Failure of Primary THA
- Being tested
- Bead placement during revision hip replacement surgery
- Keywords
- clinical outcomes, radiographic outcomes, total hip arthroplasty, survivorship
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bead placement during revision hip replacement surgeryProcedure or surgery
Tantalum beads will be placed in the surrounding pelvic and femoral bone and the polyethylene component during surgical treatment of failed primary THA components
| Study group | Role | What they receive |
|---|---|---|
| Revision Total Hip | Experimental | patients recieving a revision total hip replacement will be assessed for implant stability and wear using RSA. Tantalum beads will be placed in the polyethylene and surrounding pelvic and femoral bone. Receives: Procedure: Bead placement during revision hip replacement surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability of Acetabular and femoral components
RSA films will be taken at the prescribed time intervals to measure component mothion over time.
Measured: 1, 2, 3, 5 years after surgery
Secondary outcomes (1)
Wear of the polyethlene component
The movement of the femoral head into the polyethylenen, (wear), will be measured at the prescribed time intervals.
Measured: 1, 2, 3, 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of HipStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles R. Bragdon, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668160
- Sponsor's protocol ID
- 2012P000925
- Other IDs
- 216494
- Status last verified
- Nov 2013
- First submitted
- 10 Aug 2012
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Stability of Total Hip Arthroplasty Implants Used in Revision Surgery Using Radiostereometric Analysis (RSA)
- ClinicalTrials.gov ID
- NCT01668160
- Acronym / sponsor ID
- 2012P000925
- Conditions
- Osteoarthritis of Hip, Failure of Primary THA
- Keywords
- clinical outcomes, radiographic outcomes, total hip arthroplasty, survivorship
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 17 Aug 2012 (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 specific aim is to quantify the stability of the acetabular and femoral components of a revision total hip arthroplasty (THA) in vivo as currently performed at our institution. In this way, the investigators will gain insight into the outcome of the current state of the art of revision arthroplasty surgery. In the past, acetabular and femoral component stability has been measured using radiostereometric analysis (RSA) and when patients having revision total hip operations were compared to patients undergoing primary total hip operations it was possible to determine differences in stability and this was predictive of the intermediate to long-term performance of the acetabular and femoral reconstruction. The investigators propose to use this established, high resolution technique to assess and compare the stability of the revision implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Revision Total Hip | Experimental | Procedure: Bead placement during revision hip replacement surgerypatients recieving a revision total hip replacement will be assessed for implant stability and wear using RSA. Tantalum beads will be placed in the polyethylene and surrounding pelvic and femoral bone. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female.
- 25 to 75 years of age.
- Subjects requiring revision total hip replacement.
- Subjects who demonstrate the ability to return to MGH for follow-up for the next five years.
Key exclusion criteria (5 listed)
- Subjects with limited life span.
- Subjects with difficulty in comprehending study protocol for any reason.
- Subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, or any other major medical complication which could substantially reduce longevity, put them at further risk due to immunocompromisation or increase the risk of infection.
- Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.
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 |
|---|---|---|
| Bead placement during revision hip replacement surgeryTantalum beads will be placed in the surrounding pelvic and femoral bone and the polyethylene component during surgical treatment of failed primary THA components | Procedure or surgery | Revision Total Hip |
Primary outcome
Stability of Acetabular and femoral components
Time frame: 1, 2, 3, 5 years after surgery
RSA films will be taken at the prescribed time intervals to measure component mothion over time.
1 secondary outcome
Wear of the polyethlene component
Time frame: 1, 2, 3, 5 years after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bead placement during revision hip replacement surgery in people with Osteoarthritis of Hip and Failure of Primary THA, run by Massachusetts General Hospital 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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 5 Nov 2013. 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 was withdrawn before enrolling participants, so there are no results.
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?
Stability of Acetabular and femoral components (time frame: 1, 2, 3, 5 years after surgery). 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 5 Nov 2013.