OsteoarthritisNCT00293605
Effect of Cemented Stem Design on Periprosthetic Bone Mass Following Primary Total Hip Arthroplasty
An observational study of Osteoarthritis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Total hip replacement is a common procedure for the treatment of osteoarthrosis of the hips, the aims of this study are to determine the effect of implant stem design on bone quality surrounding the implant using three stem designs that are routinely implanted at this hospital. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Total Hip Replacement
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2004to Apr 2011
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pre-assessment clinics at Sheffield Hospitals, patients booked for hip replacements.
Who may be able to join
- patients must be aged 60 yrs or more uncomplicated primary or secondary osteoarthritis of the hip undergoing unilateral cemented total hip arthroplasty using a metal on polyethylene bearing couple.
Who cannot join
- metabolic bone disorders, systemic disorders such as rheumatoid arthritis and patients who have taken pharmacological doses of oral steroids, hormone replacement therapy, tamoxifen, calcium or vitamin D supplements within the last year. Patients with a prior history of bisphosphonates and women of child bearing age.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Orthopaedic Department, Northern General Hospital
Sheffield, South Yorkshire, S5 7AU
About this study
Total hip replacement is a common procedure for the treatment of osteoarthrosis of the hips, the aims of this study are to determine the effect of implant stem design on bone quality surrounding the implant using three stem designs that are routinely implanted at this hospital.
Read the detailed description
120 patients will undergo routine hip replacements using either the C-Stem, Exeter Stem or Charnley stem implants. Patients will be clinically evaluated pre-operatively and randomised to one of the three implants. Post-operatively, patients will be clinically reviewed for 2 years using bone mineral density scans, radiological review, blood and urine analysis for bone markers and validated questionnaires to assess clinical data (Oxford Hip and Harries Hip). Patients will be assessed for prothesis migration using the EBRA methods.
- Conditions
- Osteoarthritis
- Being tested
- Total Hip Replacement
- Keywords
- aseptic loosening, femoral stem design
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ReplacementProcedure or surgery
Implantation of one of 3 stem designs
| Study group | Role | What they receive |
|---|---|---|
| 1 | C-stem implant Receives: Procedure: Total Hip Replacement | |
| 2 | Charnley Implant Receives: Procedure: Total Hip Replacement | |
| 3 | Exeter Implant Receives: Procedure: Total Hip Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal femoral BMD change over 2 years measured by DXA
Measured: 2 years
Secondary outcomes (5)
Clinical Evaluation using patient centered questionnaire (Oxford Hip Score)
Measured: 2 years
Surgeon centered clinical assessment (Harris Hip Score)
Measured: 2 years
Plain radiographic assessment
Measured: 2 years
Biochemical markers of bone formation and resorption measured from serum and urine samples using the Elecsys system.
Measured: 2 years
Femoral prosthetic stem y-axis migration (subsidence), ans stem/shaft angulation change measured by EBRA.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2006 (estimated)
- Study startJan 2004
- Primary completionNov 2008
- Study completionApr 2011
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Andrew J Hamer, FRCS, Principal investigator, STH NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293605
- Sponsor's protocol ID
- NS200361715
- Status last verified
- May 2011
- First submitted
- 16 Feb 2006
- Last updated
- 9 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cemented Stem Design on Periprosthetic Bone Mass Following Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00293605
- Acronym / sponsor ID
- NS200361715
- Conditions
- Osteoarthritis
- Keywords
- aseptic loosening, femoral stem design
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Nov 2008 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 17 Feb 2006 (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.
Total hip replacement is a common procedure for the treatment of osteoarthrosis of the hips, the aims of this study are to determine the effect of implant stem design on bone quality surrounding the implant using three stem designs that are routinely implanted at this hospital.
Detailed description
120 patients will undergo routine hip replacements using either the C-Stem, Exeter Stem or Charnley stem implants. Patients will be clinically evaluated pre-operatively and randomised to one of the three implants. Post-operatively, patients will be clinically reviewed for 2 years using bone mineral density scans, radiological review, blood and urine analysis for bone markers and validated questionnaires to assess clinical data (Oxford Hip and Harries Hip). Patients will be assessed for prothesis migration using the EBRA methods.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Total Hip ReplacementC-stem implant |
| 2 | – | Procedure: Total Hip ReplacementCharnley Implant |
| 3 | – | Procedure: Total Hip ReplacementExeter Implant |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pre-assessment clinics at Sheffield Hospitals, patients booked for hip replacements.
Key inclusion criteria (1 listed)
- patients must be aged 60 yrs or more uncomplicated primary or secondary osteoarthritis of the hip undergoing unilateral cemented total hip arthroplasty using a metal on polyethylene bearing couple.
Key exclusion criteria (1 listed)
- metabolic bone disorders, systemic disorders such as rheumatoid arthritis and patients who have taken pharmacological doses of oral steroids, hormone replacement therapy, tamoxifen, calcium or vitamin D supplements within the last year. Patients with a prior history of bisphosphonates and women of child bearing age.
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 |
|---|---|---|
| Total Hip ReplacementImplantation of one of 3 stem designs | Procedure or surgery | 1, 2, 3 |
Primary outcome
Proximal femoral BMD change over 2 years measured by DXA
Time frame: 2 years
5 secondary outcomes
Clinical Evaluation using patient centered questionnaire (Oxford Hip Score)
Time frame: 2 years
Surgeon centered clinical assessment (Harris Hip Score)
Time frame: 2 years
Plain radiographic assessment
Time frame: 2 years
Biochemical markers of bone formation and resorption measured from serum and urine samples using the Elecsys system.
Time frame: 2 years
Femoral prosthetic stem y-axis migration (subsidence), ans stem/shaft angulation change measured by EBRA.
Time frame: 2 years
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 9 May 2011.
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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 J Hamer, FRCS principal investigator
STH NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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 9 May 2011. 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 Kingdom. 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?
Proximal femoral BMD change over 2 years measured by DXA (time frame: 2 years). 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 9 May 2011.