Total Knee ArthroplastyPhase 4HLSNCT02355652
Cemented Versus Uncemented Total Knee Arthroplasty : a Prospective Randomized Study
A Phase 4 study testing Surgical total knee replacement using cemented components and Surgical total knee replacement using uncemented components in people with Total Knee Arthroplasty, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The goal of this prospective randomized double-blind study is to compare clinical and radiological results of cemented and uncemented total knee arthroplasty (TKA). Two hundred and fifty patients will be randomized in two groups : cemented TKA and uncemented TKA. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Surgical total knee replacement using cemented components and Surgical total knee replacement using uncemented components
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Mar 2017
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee osteoarthritis
- Need for a total knee arthroplasty
Who cannot join
- Age < 50 or > 80
- Need for a different procedure than a TKA
- Preoperative knee flexion < 90°
- Need for a TKA associated with a combined femoral or tibial osteotomy
- Knee already operated except for arthroscopy
- Mediocre bone quality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Surgical Strategies of Total Knee Arthroplasty : Cemented Versus Uncemented HLS Knee-Tec Prosthesis System. A Prospective Randomized Study.
The goal of this prospective randomized double-blind study is to compare clinical and radiological results of cemented and uncemented total knee arthroplasty (TKA).
Two hundred and fifty patients will be randomized in two groups : cemented TKA and uncemented TKA.
The primary outcome is the comparison of the International Knee Society (IKS) Score revised in 2011 at one year postoperative.
The second outcome is the comparison of standard one year-postoperative x-rays looking for signs of loosening.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Surgical total knee replacement using cemented components, Surgical total knee replacement using uncemented components
- Keywords
- Total knee arthroplasty, IKS Score, cemented, uncemented
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical total knee replacement using cemented componentsDevice
Each patient of this arm will go under a surgical procedure of total knee replacement (or total knee arthroplasty) using cemented femoral and tibial prosthetic components.
Surgical total knee replacement using uncemented componentsDevice
Each patient of this arm will go under a surgical procedure of total knee replacement (or total knee arthroplasty) using uncemented femoral and tibial prosthetic components.
| Study group | Role | What they receive |
|---|---|---|
| Cemented TKA | Active comparator | Not described Receives: Device: Surgical total knee replacement using cemented components |
| Uncemented TKA | Active comparator | Not described Receives: Device: Surgical total knee replacement using uncemented components |
What is being measured
The primary outcome is the main question the study is designed to answer.
IKS 2011 Score measuring the clinical results of TKA
IKS 2011 Score will be assessed for each patients and the mean IKS Score will be compared between both arms
Measured: One year postoperative
Secondary outcomes (1)
Number of patients in each arm with radiological loosening signs of the TKA components
At one year postoperative, each patient will go under standard radiological exam seeking for signs of loosening of the prosthetic components. The number of patients presenting radiological signs of loosening will be compared between both arms.
Measured: One year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2017 (estimated)
- Study completionMar 2017 (estimated)
Why it stopped: an other study will start with new outcome measures
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe NEYRET, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355652
- Sponsor's protocol ID
- 2014.883
- Acronym
- HLS
- Status last verified
- Jan 2017
- First submitted
- 26 Jan 2015
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Surgical Strategies of Total Knee Arthroplasty : Cemented Versus Uncemented HLS Knee-Tec Prosthesis System. A Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT02355652
- Acronym / sponsor ID
- HLS / 2014.883
- Conditions
- Total Knee Arthroplasty
- Keywords
- Total knee arthroplasty, IKS Score, cemented, uncemented
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: an other study will start with new outcome measures
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 4 Feb 2015 (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 goal of this prospective randomized double-blind study is to compare clinical and radiological results of cemented and uncemented total knee arthroplasty (TKA).
Two hundred and fifty patients will be randomized in two groups : cemented TKA and uncemented TKA.
The primary outcome is the comparison of the International Knee Society (IKS) Score revised in 2011 at one year postoperative.
The second outcome is the comparison of standard one year-postoperative x-rays looking for signs of loosening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cemented TKA | Active comparator | Device: Surgical total knee replacement using cemented components |
| Uncemented TKA | Active comparator | Device: Surgical total knee replacement using uncemented components |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Knee osteoarthritis
- Need for a total knee arthroplasty
Key exclusion criteria (6 listed)
- Age < 50 or > 80
- Need for a different procedure than a TKA
- Preoperative knee flexion < 90°
- Need for a TKA associated with a combined femoral or tibial osteotomy
- Knee already operated except for 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 |
|---|---|---|
| Surgical total knee replacement using cemented componentsEach patient of this arm will go under a surgical procedure of total knee replacement (or total knee arthroplasty) using cemented femoral and tibial prosthetic components. | Device | Cemented TKA |
| Surgical total knee replacement using uncemented componentsEach patient of this arm will go under a surgical procedure of total knee replacement (or total knee arthroplasty) using uncemented femoral and tibial prosthetic components. | Device | Uncemented TKA |
Primary outcome
IKS 2011 Score measuring the clinical results of TKA
Time frame: One year postoperative
IKS 2011 Score will be assessed for each patients and the mean IKS Score will be compared between both arms
1 secondary outcome
Number of patients in each arm with radiological loosening signs of the TKA components
Time frame: One year postoperative
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 6 Jan 2017.
- Related InfoLink provided by the sponsor.
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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, Pr 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 Phase 4 study testing Surgical total knee replacement using cemented components and Surgical total knee replacement using uncemented components in people with Total Knee Arthroplasty, 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 2 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 6 Jan 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
IKS 2011 Score measuring the clinical results of TKA (time frame: One year postoperative). 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 6 Jan 2017.