ArthroplastyNCT03081260
Long-term Evaluation Protocol (12 Months Postoperative) of Total Knee Prostheses Anatomic With Resurfaced Patella Versus Non-resurfaced Patella in Patients Requiring Total Knee Arthroplasty
A study testing Patellar resurfacing and Patellar non-resurfacing in people with Arthroplasty, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Total knee arthroplasty is a frequent surgery in France. It currently represents 70,000 interventions per year. The total knee prosthesis is also called tri-compartmental because it allows articulation between the femur and the tibia but also between the femur and the patella. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty
- What is being tested?
- Patellar resurfacing and Patellar non-resurfacing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2017to 28 Feb 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female (age ≥ 18 years)
- Diagnosis of knee arthrosis (internal femoro-tibial arthrosis, external femorotibial osteoarthritis, femoro-patellar arthrosis)
- Indication of total first-line knee arthroplasty
Who cannot join
- Patient whose surgical complexity requires the placement of a strained prosthesis (ligament laxity, bone loss).
- Refusal to participate in the study
- Pregnant women, parturients or nursing mothers
- Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care, persons admitted to a health or social institution for purposes other than research
- Minor Patients
- Major persons who are subject to a legal protection measure or are unable to express their consent
- Patient not affiliated to a social security scheme
- Patient participating in other interventional research excluding routine care studies not interfering with analysis of primary endpoint
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Evaluation Protocol (12 Months Postoperative) of Total Knee Prostheses Anatomic With Resurfaced Patella Versus Non-resurfaced Patella in Patients Requiring Total Knee Arthroplasty Prospective, Monocentric, Randomized, Open-label Study
Total knee arthroplasty is a frequent surgery in France. It currently represents 70,000 interventions per year. The total knee prosthesis is also called tri-compartmental because it allows articulation between the femur and the tibia but also between the femur and the patella.
The patella belongs to the extensor system. It articulates with the femoral trochlea in which it slides. It has an important biomechanical role on the quadriceps strength in addition to allowing flexion-extension movements.
Read more
In the case of resurfacing, the joint face of the patella is cut off; A convex polyethylene implant is sealed with cement using studs on the same face.
In case of non-resurfacing, the surgeon leaves in place the cartilage of the patella which will be in direct contact with the femoral prosthetic trochlea.
Both methods have advantages and disadvantages. For some implants, it is recommended to resurface the patella because the implant is not very tolerant with the native patella. Other implants have been designed to be better adapted to the preservation of patellar cartilage.
There is currently no evidence that one method is superior to the other on new generation implants known as "patellar friendly".
It seems necessary to compare both methods in terms of long-term postsurgery results.
Read the detailed description
The analysis of the primary endpoint (International Knee Society score (IKS score)) will be based on the assumption that the postsurgery score will be identical in both groups. The t test for independent samples will be used to test this hypothesis.
- Conditions
- Arthroplasty
- Being tested
- Patellar resurfacing, Patellar non-resurfacing
- Keywords
- Total Knee Arthroplasty, Patella, Resurfacing, IKS score
- Medical subject headings
- Patella Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patellar resurfacingOther
The resurfacing of the patella is generally done at the end of the surgery, after having ejected the patella. A frontal bone cut is made using a dedicated ancillary to remove the entire cartilage. Orifices are then made in the patella so that the polyethylene implant can be accommodated with studs which will be cemented on the joint face of the ball joint.
Patellar non-resurfacingOther
Non-resurfacing of the patella does not involve any additional surgical action
| Study group | Role | What they receive |
|---|---|---|
| Patellar resurfacing | Other | Patellar resurfacing during the total knee prosthesis Anatomic surgery Receives: Other: Patellar resurfacing |
| Patellar non-resurfacing | Other | Patellar non-resurfacing during the total knee prosthesis Anatomic surgery Receives: Other: Patellar non-resurfacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure of International Knee Society score (IKS score)
The comparison of the IKS (International Knee Society) scores (2011 version) will be done between both groups.
Measured: 12 months after surgery
Secondary outcomes (2)
abnormality of the patellar stroke
Presence of an abnormality of the patellar stroke with the type of tilting, subluxation or dislocation of the patella on the X-ray images.
Measured: 12 months after surgery
Measure of the forgotten joint score
The comparison of the forgotten joint score will be done between both groups.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start3 Apr 2017
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
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 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien Lustig, MD, Principal investigator, Hôpital de la Croix-Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081260
- Sponsor's protocol ID
- 69HCL16_0645
- Other IDs
- 2016-A01697-44
- Status last verified
- Sep 2025
- First submitted
- 9 Mar 2017
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Deroche E, Batailler C, Swan J, Sappey-Marinier E, Neyret P, Servien E, Lustig S. No difference between resurfaced and non-resurfaced patellae with a modern prosthesis design: a prospective randomized study of 250 total knee arthroplasties. Knee Surg Sports Traumatol Arthrosc. 2022 Mar;30(3):1025-1038. doi: 10.1007/s00167-021-06521-y. Epub 2021 Mar 4.
PubMed 33661323
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Evaluation Protocol (12 Months Postoperative) of Total Knee Prostheses Anatomic With Resurfaced Patella Versus Non-resurfaced Patella in Patients Requiring Total Knee Arthroplasty Prospective, Monocentric, Randomized, Open-label Study
- ClinicalTrials.gov ID
- NCT03081260
- Acronym / sponsor ID
- 69HCL16_0645
- Conditions
- Arthroplasty
- Keywords
- Total Knee Arthroplasty, Patella, Resurfacing, IKS score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 16 Mar 2017 (actual)
- 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 knee arthroplasty is a frequent surgery in France. It currently represents 70,000 interventions per year. The total knee prosthesis is also called tri-compartmental because it allows articulation between the femur and the tibia but also between the femur and the patella.
The patella belongs to the extensor system. It articulates with the femoral trochlea in which it slides. It has an important biomechanical role on the quadriceps strength in addition to allowing flexion-extension movements.
In the case of resurfacing, the joint face of the patella is cut off; A convex polyethylene implant is sealed with cement using studs on the same face.
In case of non-resurfacing, the surgeon leaves in place the cartilage of the patella which will be in direct contact with the femoral prosthetic trochlea.
Both methods have advantages and disadvantages. For some implants, it is recommended to resurface the patella because the implant is not very tolerant with the native patella. Other implants have been designed to be better adapted to the preservation of patellar cartilage.
There is currently no evidence that one method is superior to the other on new generation implants known as "patellar friendly".
It seems necessary to compare both methods in terms of long-term postsurgery results.
Detailed description
The analysis of the primary endpoint (International Knee Society score (IKS score)) will be based on the assumption that the postsurgery score will be identical in both groups. The t test for independent samples will be used to test this hypothesis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patellar resurfacing | Other | Other: Patellar resurfacingPatellar resurfacing during the total knee prosthesis Anatomic surgery |
| Patellar non-resurfacing | Other | Other: Patellar non-resurfacingPatellar non-resurfacing during the total knee prosthesis Anatomic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female (age ≥ 18 years)
- Diagnosis of knee arthrosis (internal femoro-tibial arthrosis, external femorotibial osteoarthritis, femoro-patellar arthrosis)
- Indication of total first-line knee arthroplasty
Key exclusion criteria (8 listed)
- Patient whose surgical complexity requires the placement of a strained prosthesis (ligament laxity, bone loss).
- Refusal to participate in the study
- Pregnant women, parturients or nursing mothers
- Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care, persons admitted to a health or social institution for purposes other than research
- Minor Patients
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 |
|---|---|---|
| Patellar resurfacingThe resurfacing of the patella is generally done at the end of the surgery, after having ejected the patella. A frontal bone cut is made using a dedicated ancillary to remove the entire cartilage. Orifices are then made in the patella so that the polyethylene implant can be accommodated with studs which will be cemented on the joint face of the ball joint. | Other | Patellar resurfacing |
| Patellar non-resurfacingNon-resurfacing of the patella does not involve any additional surgical action | Other | Patellar non-resurfacing |
Primary outcome
measure of International Knee Society score (IKS score)
Time frame: 12 months after surgery
The comparison of the IKS (International Knee Society) scores (2011 version) will be done between both groups.
2 secondary outcomes
abnormality of the patellar stroke
Time frame: 12 months after surgery
Measure of the forgotten joint score
Time frame: 12 months after surgery
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 3 Oct 2025.
- Results publication: PubMed 33661323Deroche E, Batailler C, Swan J, Sappey-Marinier E, Neyret P, Servien E, Lustig S. No difference between resurfaced and non-resurfaced patellae with a modern prosthesis design: a prospective randomized study of 250 total knee arthroplasties. Knee Surg Sports Traumatol Arthrosc. 2022 Mar;30(3):1025-1038. doi: 10.1007/s00167-021-06521-y. Epub 2021 Mar 4.
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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.
Sebastien Lustig, MD principal investigator
Hôpital de la Croix-Rousse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patellar resurfacing and Patellar non-resurfacing in people with 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 3 inclusion and 8 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 3 Oct 2025. 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?
measure of International Knee Society score (IKS score) (time frame: 12 months after surgery). 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 NCT03081260, 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 3 Oct 2025.