Osteoarthritis, HipPhase 2NCT00319085
Preheating of Femur Component in Hybrid Total Hip Arthroplasty
A Phase 2 study testing Total hip replacement (Preheating of femur stem) in people with Osteoarthritis, Hip, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
Background Recently published studies confirm that preheating of femoral component enhances shear strength of implant-cement interface. Both Iesaka et al 2003 and Jafri et al 2004 showed reduction in cement porosity on cement-implant interface with preheated femur components. Read more about this study
- Who is it for?
- Ages 70 to 85 years
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Total hip replacement (Preheating of femur stem)
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- May 2006to Apr 2010
- Phase
- Phase 2
- 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 70 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- The patients suffering of hip osteoarthritis
Who cannot join
- The patients with ASA score >II
- The patients with cancer
- The secondary coxarthrosis after the trauma
- Any vascular or neuromuscular diseases affecting the hip.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Preheated and Non-preheated Femur Component in Hybrid Total Hip Arthroplasty (THA) A Prospective Randomized Study of the 80 THA Using Radiostereometry.
Background
- Recently published studies confirm that preheating of femoral component enhances shear strength of implant-cement interface. Both Iesaka et al 2003 and Jafri et al 2004 showed reduction in cement porosity on cement-implant interface with preheated femur components. We will use the radiostereometry analysis (RSA) to investigate how the preheating of femur component influence on prosthesis survivorship. There are no clinical controlled studies performed to the date.
Read more
The aim of the study
- Comparison of the migration rates between preheated and non-preheated femur components, analyzed with RSA.
Methods
- Randomization of 80 patients into 2 groups with 40 in each. All patients will undergo standard hybrid total hip replacement. In group one the femur component (Bi-Metric, Interlock Biomet) will be preheated to 40 degrees of Celsius before cementation. In group two: the control group, the femur component will be of room temperature. We will measure the temperature at cement bone interface during the operation with use of thermocouple electrodes inserted through separate drill hole in the femur. The measurements will be recorded every 10 seconds. The patients will follow the standard postoperative rehabilitation program.
- The RSA analysis will be performed the first day after the operation and at 3, 12, 24 months postoperatively.
- The Dual-energy X-ray absorptiometry scanning (DEXA) of the femur will be performed at the first week after the operation and at 12 and 24 months postoperatively.
- The patients will be followed both clinically and radiologically at 1 and 2 years after the operation (Harris Hip Score).
- The results will be expressed as mean + SD (in mm). ANOVA statistical analysis will be used to confirm the differences between the groups.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Total hip replacement (Preheating of femur stem)
- Keywords
- Arthroplasty,, Hip,, Pre-heating,, Radiostereometric analysis,, Dual-Energy Radiographic Absorptiometry,
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip replacement (Preheating of femur stem)Procedure or surgery
Total hybrid hip arthroplasty, cementation of femural component, preheating, radiostereometry, DEXA
What is being measured
The primary outcome is the main question the study is designed to answer.
Stem migration in mm
Measured: 2 years
Secondary outcomes (3)
Bone mineral density g/cm2
Measured: 2 years
Temperature at bone-cement interface, degrees in Celsius
Measured: peroperatively
Serum- Titanium measurements in blood samples
Measured: Not defined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startMay 2006
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mogens B Jørgensen, M.D., Principal investigator, Northern Orthopaedic Division, Aalborg University Hospital, DenmarkMogens B Laursen, M.D., Ph.D, Principal investigator, Northern Orthopaedic Division, Aalborg University Hospital, DenmarkLotte Borgwardt, dr., Principal investigator, Frederikberg Hospital, CopenhagenKjeld Søballe, Ph.D., MD., Study chair, University Hospital of AarhusPoul T Nielsen, M.D., Study director, Northern Orthopaedic Division, Aalborg University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319085
- Sponsor's protocol ID
- ON-04-008a-JPE
- Status last verified
- Apr 2015
- First submitted
- 27 Apr 2006
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Preheated and Non-preheated Femur Component in Hybrid Total Hip Arthroplasty (THA) A Prospective Randomized Study of the 80 THA Using Radiostereometry.
- ClinicalTrials.gov ID
- NCT00319085
- Acronym / sponsor ID
- ON-04-008a-JPE
- Conditions
- Osteoarthritis, Hip
- Keywords
- Arthroplasty,, Hip,, Pre-heating,, Radiostereometric analysis,, Dual-Energy Radiographic Absorptiometry,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 27 Apr 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.
Background
- Recently published studies confirm that preheating of femoral component enhances shear strength of implant-cement interface. Both Iesaka et al 2003 and Jafri et al 2004 showed reduction in cement porosity on cement-implant interface with preheated femur components. We will use the radiostereometry analysis (RSA) to investigate how the preheating of femur component influence on prosthesis survivorship. There are no clinical controlled studies performed to the date.
The aim of the study
- Comparison of the migration rates between preheated and non-preheated femur components, analyzed with RSA.
Methods
- Randomization of 80 patients into 2 groups with 40 in each. All patients will undergo standard hybrid total hip replacement. In group one the femur component (Bi-Metric, Interlock Biomet) will be preheated to 40 degrees of Celsius before cementation. In group two: the control group, the femur component will be of room temperature. We will measure the temperature at cement bone interface during the operation with use of thermocouple electrodes inserted through separate drill hole in the femur. The measurements will be recorded every 10 seconds. The patients will follow the standard postoperative rehabilitation program.
- The RSA analysis will be performed the first day after the operation and at 3, 12, 24 months postoperatively.
- The Dual-energy X-ray absorptiometry scanning (DEXA) of the femur will be performed at the first week after the operation and at 12 and 24 months postoperatively.
- The patients will be followed both clinically and radiologically at 1 and 2 years after the operation (Harris Hip Score).
- The results will be expressed as mean + SD (in mm). ANOVA statistical analysis will be used to confirm the differences between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 70 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- The patients suffering of hip osteoarthritis
Key exclusion criteria (4 listed)
- The patients with ASA score >II
- The patients with cancer
- The secondary coxarthrosis after the trauma
- Any vascular or neuromuscular diseases affecting the hip.
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 replacement (Preheating of femur stem)Total hybrid hip arthroplasty, cementation of femural component, preheating, radiostereometry, DEXA | Procedure or surgery | – |
Primary outcome
Stem migration in mm
Time frame: 2 years
3 secondary outcomes
Bone mineral density g/cm2
Time frame: 2 years
Temperature at bone-cement interface, degrees in Celsius
Time frame: peroperatively
Serum- Titanium measurements in blood samples
Time frame: Not defined
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 10 Apr 2015.
Related trials for Osteoarthritis, Hip
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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.
Mogens B Jørgensen, M.D. principal investigator
Northern Orthopaedic Division, Aalborg University Hospital, Denmark
Mogens B Laursen, M.D., Ph.D principal investigator
Northern Orthopaedic Division, Aalborg University Hospital, Denmark
Lotte Borgwardt, dr. principal investigator
Frederikberg Hospital, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Total hip replacement (Preheating of femur stem) in people with Osteoarthritis, Hip, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 4 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 10 Apr 2015. 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 Denmark. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Stem migration in mm (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 10 Apr 2015.