OsteoarthritisNCT00175162
A Comparison of Fixation Method in Total Knee Arthroplasty - Low Viscosity Versus High Viscosity Bone Cement
A study testing Osteopal G vs. Refobacin-Palacos R bone cement in people with Osteoarthritis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to compare the early migration and periprosthetic bone changes of two total knee arthroplasties fixated with two different type bone cement. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Osteopal G vs. Refobacin-Palacos R bone cement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Start not givento Dec 2010
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with one- or double-sided primary knee arthrosis.
- Patients with a sufficient bone quality for implantation of knee prosthesis.
- Informed and written patient consent.
Who cannot join
- Patients with neuromuscular or vascular diseases in the affected leg.
- Patients who peroperatively are estimated unsuitable for knee arthroplasty e.g. due to bone cysts or dilution of the bone mass.
- Patients who use non-steroid anti-inflammatory drugs (NSAID) and cannot refrain from taking them postoperatively (this includes COX-2-inhibitors).
- Patients with osteoporosis estimated from the preoperative x-ray or former diagnosis of osteoporo-sis.
- Patients with knee arthrosis following fracture sequelae.
- Women, who are pregnant or are at risk of getting pregnant throughout the 2 year follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Fixation Method in Total Knee Arthroplasty - Low Viscosity Versus High Viscosity Bone Cement. A Prospective Randomized Migration- and Bone Density Study on Primary Cemented Knee Implants.
The purpose of this study is to compare the early migration and periprosthetic bone changes of two total knee arthroplasties fixated with two different type bone cement.
Read the detailed description
Around 4% of total knee arthroplasties (TKA) are revised 15 years after the primary operation, most due to loosening of the implant. About 70 % TKA are fixed with bone cement and in general the results after total knee arthroplasty are excellent and with the existing technique about 95% well functioning prostheses can be expected 10 years post surgery. The most serious late complication to surgery is aseptic loosening of the implants; and this remains one of the main courses of failure of both uncemented and cemented total knee implants.
Implant design, method of fixation, the quality of bone cement, surgerytechnique and the bone mass density are some of the factors that have a large influence on implant stability. Fixation of the tibia baseplates in total knee arthroplasty can be obtained by different type bone cement.
In this project we are using a modular tibia component with a central wedge-shaped stem. Upon randomization at surgery the implant is consolidated in the bone with either low-viscosity or high-viscosity bone cement.
The purpose of this study is to compare the early migration of a total knee implant fixated with two different bone cements using RSA (radio stereophotogrammetric analysis) for evaluation. Furthermore, we will make research into the periprosthetic bone and its changes post surgery using DEXA. Finally, the extend of the expected micromovements between the polyethylen liner and the metal backing of the titanium plateau will be compared and taken into account with the results.
Several factors can influence the long-term survival of cemented TKA. Bone-sclerosing at the tibia condyles may induce a problem with cement penetration into the cancellous bone. Furthermore, blood-contamination in the cancellous bone may reduce the shear-strength at the bone-cement site by 50%. A solid cement-implant interface limits the amount of debris in the interface bringing down the risk of radiolucent lines and osteolysis. The tibial implant used in this study is designed with a rim under the plateau to support the cement layer on the tibial condyles at the time of fixation. The implant has a stem making it more resistant to shearing forces. In this study we primarily consider the bone cement viscosity on the outcome. Both types are used in hip-arthroplasties with good results.
To evaluate both the implant-bone micromotions and the polyethylen-implant micromovements metal markers have been placed on the tibial implants pre-operatively. They will also be inserted into the tibial bone and into the tibial polyethylen intra-operatively allowing us to evaluate stereo x-rays by a photogrammetric computer analyses called RSA at the Orthopaedic Center, Aarhus University Hospital. Follow-up stereo x-rays will be scheduled for 1 week, 3 months, 6 month, 1 years and 2 years post-surgery. Periprostetic bone density will be evaluated at 1 week, 1 year and 2 years upon inclusion at the Orthopaedic Center, Aarhus University Hospital.
- Conditions
- Osteoarthritis
- Being tested
- Osteopal G vs. Refobacin-Palacos R bone cement
- Keywords
- RSA, DEXA, Genoarthrosis, Knee Arthroplasty, Micromotion of polyethylene liner, Cement
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopal G vs. Refobacin-Palacos R bone cementDevice
Also called Osteopal G bone cement, refobacin-palacos R bone cement
Bone cement
| Study group | Role | What they receive |
|---|---|---|
| Osteopal G bone cement | Active comparator | Not described Receives: Device: Osteopal G vs. Refobacin-Palacos R bone cement |
| Refobacin-Palacos R bone cement | Active comparator | Not described Receives: Device: Osteopal G vs. Refobacin-Palacos R bone cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tibial prosthesis part migration evaluated by RSA.
Measured: 2011
Secondary outcomes (1)
Micromotion of the modular polyethylen liner in both type prostheses evaluated by RSA estimating the role of wear.
Measured: 2011
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 completionDec 2010
Why it stopped: No financing possible
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 University of AarhusThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- Kjeld Søballe, MD, Prof., Principal investigator, Orthopaedic Center, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C, Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175162
- Sponsor's protocol ID
- 20030249
- Status last verified
- Oct 2010
- First submitted
- 10 Sep 2005
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Fixation Method in Total Knee Arthroplasty - Low Viscosity Versus High Viscosity Bone Cement. A Prospective Randomized Migration- and Bone Density Study on Primary Cemented Knee Implants.
- ClinicalTrials.gov ID
- NCT00175162
- Acronym / sponsor ID
- 20030249
- Conditions
- Osteoarthritis
- Keywords
- RSA, DEXA, Genoarthrosis, Knee Arthroplasty, Micromotion of polyethylene liner, Cement
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No financing possible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Zimmer Biomet
- Study completion
- Dec 2010
- 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 compare the early migration and periprosthetic bone changes of two total knee arthroplasties fixated with two different type bone cement.
Detailed description
Around 4% of total knee arthroplasties (TKA) are revised 15 years after the primary operation, most due to loosening of the implant. About 70 % TKA are fixed with bone cement and in general the results after total knee arthroplasty are excellent and with the existing technique about 95% well functioning prostheses can be expected 10 years post surgery. The most serious late complication to surgery is aseptic loosening of the implants; and this remains one of the main courses of failure of both uncemented and cemented total knee implants.
Implant design, method of fixation, the quality of bone cement, surgerytechnique and the bone mass density are some of the factors that have a large influence on implant stability. Fixation of the tibia baseplates in total knee arthroplasty can be obtained by different type bone cement.
In this project we are using a modular tibia component with a central wedge-shaped stem. Upon randomization at surgery the implant is consolidated in the bone with either low-viscosity or high-viscosity bone cement.
The purpose of this study is to compare the early migration of a total knee implant fixated with two different bone cements using RSA (radio stereophotogrammetric analysis) for evaluation. Furthermore, we will make research into the periprosthetic bone and its changes post surgery using DEXA. Finally, the extend of the expected micromovements between the polyethylen liner and the metal backing of the titanium plateau will be compared and taken into account with the results.
Several factors can influence the long-term survival of cemented TKA. Bone-sclerosing at the tibia condyles may induce a problem with cement penetration into the cancellous bone. Furthermore, blood-contamination in the cancellous bone may reduce the shear-strength at the bone-cement site by 50%. A solid cement-implant interface limits the amount of debris in the interface bringing down the risk of radiolucent lines and osteolysis. The tibial implant used in this study is designed with a rim under the plateau to support the cement layer on the tibial condyles at the time of fixation. The implant has a stem making it more resistant to shearing forces. In this study we primarily consider the bone cement viscosity on the outcome. Both types are used in hip-arthroplasties with good results.
To evaluate both the implant-bone micromotions and the polyethylen-implant micromovements metal markers have been placed on the tibial implants pre-operatively. They will also be inserted into the tibial bone and into the tibial polyethylen intra-operatively allowing us to evaluate stereo x-rays by a photogrammetric computer analyses called RSA at the Orthopaedic Center, Aarhus University Hospital. Follow-up stereo x-rays will be scheduled for 1 week, 3 months, 6 month, 1 years and 2 years post-surgery. Periprostetic bone density will be evaluated at 1 week, 1 year and 2 years upon inclusion at the Orthopaedic Center, Aarhus University Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopal G bone cement | Active comparator | Device: Osteopal G vs. Refobacin-Palacos R bone cement |
| Refobacin-Palacos R bone cement | Active comparator | Device: Osteopal G vs. Refobacin-Palacos R bone cement |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients with one- or double-sided primary knee arthrosis.
- Patients with a sufficient bone quality for implantation of knee prosthesis.
- Informed and written patient consent.
Key exclusion criteria (6 listed)
- Patients with neuromuscular or vascular diseases in the affected leg.
- Patients who peroperatively are estimated unsuitable for knee arthroplasty e.g. due to bone cysts or dilution of the bone mass.
- Patients who use non-steroid anti-inflammatory drugs (NSAID) and cannot refrain from taking them postoperatively (this includes COX-2-inhibitors).
- Patients with osteoporosis estimated from the preoperative x-ray or former diagnosis of osteoporo-sis.
- Patients with knee arthrosis following fracture sequelae.
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 |
|---|---|---|
| Osteopal G vs. Refobacin-Palacos R bone cementAlso: Osteopal G bone cement, refobacin-palacos R bone cementBone cement | Device | Osteopal G bone cement, Refobacin-Palacos R bone cement |
Primary outcome
Tibial prosthesis part migration evaluated by RSA.
Time frame: 2011
1 secondary outcome
Micromotion of the modular polyethylen liner in both type prostheses evaluated by RSA estimating the role of wear.
Time frame: 2011
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 19 Dec 2022.
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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.
Kjeld Søballe, MD, Prof. principal investigator
Orthopaedic Center, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C, Denmark.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopal G vs. Refobacin-Palacos R bone cement in people with Osteoarthritis, run by University of Aarhus 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 3 inclusion and 6 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 19 Dec 2022. 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.
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?
Tibial prosthesis part migration evaluated by RSA. (time frame: 2011). 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 19 Dec 2022.