Osteoarthritis, KneeNCT00132587
Total Knee Arthroplasty (TKA) Cemented Versus Cementless
A study testing cement Palacos R40 and LV40 in people with Osteoarthritis, Knee, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The aim of the study is to analyse and to compare the quality of fixation of a femoral implant with or without cement. One hundred thirty patients will be operated on and included with 2 groups, the first one with TKA all cemented and the second one with TKA with a cementless femoral implant. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- cement Palacos R40 and LV40
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2004to Mar 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis (medial and/or lateral femoro-tibial arthritis and/or patellofemoral arthritis)
- Indication of surgical treatment by total knee arthroplasty
- Age between 50 and 90 years
- Acceptance and signature to participate
Who cannot join
- Rheumatoid or other inflammatory arthritis
- Association with other surgical procedure (osteotomy)
- Range of motion inferior to 90°
- Previous knee surgery (except arthroscopy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Study of 130 Total Knee Arthroplasty With Cemented Femoral Implant Versus Cementless
The aim of the study is to analyse and to compare the quality of fixation of a femoral implant with or without cement.
One hundred thirty patients will be operated on and included with 2 groups, the first one with TKA all cemented and the second one with TKA with a cementless femoral implant. The study criteria include the IKS (International Knee Society) score and the analysis of a radiolucent line at the femur.
Patients will be reviewed at 2, 6 and 12 months.
- Conditions
- Osteoarthritis, Knee
- Being tested
- cement Palacos R40 and LV40
- Keywords
- Knee arthroplasty, Femoral loosening, Total Knee Arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cement Palacos R40 and LV40Device
What is being measured
The primary outcome is the main question the study is designed to answer.
IKS (International Knee Society) score at 12 months
Secondary outcomes (1)
Analysis of femoral radiolucent line at the X-rays (profile and anterior-posterior [AP] view) at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startMar 2004
- Primary completionDec 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Enrolment
- 130 participants
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Philippe NEYRET, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132587
- Sponsor's protocol ID
- 2003.313
- Status last verified
- Jun 2008
- First submitted
- 19 Aug 2005
- Last updated
- 28 May 2019
- Results posted
- No
Publications
Demey G, Servien E, Pinaroli A, Lustig S, Ait Si Selmi T, Neyret P. The influence of femoral cementing on perioperative blood loss in total knee arthroplasty: a prospective randomized study. J Bone Joint Surg Am. 2010 Mar;92(3):536-41. doi: 10.2106/JBJS.H.01159.
PubMed 20194310
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of 130 Total Knee Arthroplasty With Cemented Femoral Implant Versus Cementless
- ClinicalTrials.gov ID
- NCT00132587
- Acronym / sponsor ID
- 2003.313
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee arthroplasty, Femoral loosening, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 22 Aug 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 aim of the study is to analyse and to compare the quality of fixation of a femoral implant with or without cement.
One hundred thirty patients will be operated on and included with 2 groups, the first one with TKA all cemented and the second one with TKA with a cementless femoral implant. The study criteria include the IKS (International Knee Society) score and the analysis of a radiolucent line at the femur.
Patients will be reviewed at 2, 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Osteoarthritis (medial and/or lateral femoro-tibial arthritis and/or patellofemoral arthritis)
- Indication of surgical treatment by total knee arthroplasty
- Age between 50 and 90 years
- Acceptance and signature to participate
Key exclusion criteria (4 listed)
- Rheumatoid or other inflammatory arthritis
- Association with other surgical procedure (osteotomy)
- Range of motion inferior to 90°
- Previous knee surgery (except arthroscopy)
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 |
|---|---|---|
| cement Palacos R40 and LV40 | Device | – |
Primary outcome
IKS (International Knee Society) score at 12 months
1 secondary outcome
Analysis of femoral radiolucent line at the X-rays (profile and anterior-posterior [AP] view) at 12 months
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 28 May 2019.
- Results publication: PubMed 20194310Demey G, Servien E, Pinaroli A, Lustig S, Ait Si Selmi T, Neyret P. The influence of femoral cementing on perioperative blood loss in total knee arthroplasty: a prospective randomized study. J Bone Joint Surg Am. 2010 Mar;92(3):536-41. doi: 10.2106/JBJS.H.01159.
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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.
Philippe NEYRET, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cement Palacos R40 and LV40 in people with Osteoarthritis, Knee, run by Hospices Civils de Lyon at 1 site in France.
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 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 28 May 2019. 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 France. 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?
IKS (International Knee Society) score at 12 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00132587, which also lists 1 linked publication.
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 28 May 2019.