Knee ArthroplastyCR-PSNCT07757581
Customized Knee Arthroplasty With or Without Posterior Cruciate Ligament Retention: A CR-PS Approach
A study testing Implantation surgery for CR and PS knee-joint prostheses used in the orthopedic surgery department's routine practice in people with Knee Arthroplasty and Osteoarthritis, Knee, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
Trial summary
Background and Rationale: Conventional mechanical implantation of total knee arthroplasty (TKA) aims to establish a lower-limb mechanical axis of 180°. Computer-assisted personalized implantation aims to restore a pre-arthritic alignment while respecting the soft-tissue envelope of the knee. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroplasty, Osteoarthritis, Knee
- What is being tested?
- Implantation surgery for CR and PS knee-joint prostheses used in the orthopedic surgery department's routine practice
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2024to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient information provided and signed written informed consent obtained in duplicate
- Male and female participants aged 18 years or older
- Primary total knee arthroplasty for knee osteoarthritis performed in the orthopaedic surgery department
Who cannot join
- History of posterior cruciate ligament (PCL) rupture or prior ligamentoplasty
- History of ipsilateral femur or tibia fracture
- Coronal plane axial deviation greater than 15 degrees (HKA < 165° or > 195°)
- Flexion contracture (flexum) greater than 15 degrees
- Tibial slope greater than 10 degrees
- Patient deprived of liberty by judicial or administrative decision
Show all 12Show fewer
- Patient not affiliated with or beneficiary of a national social security scheme
- Patient unable to understand French
- Patient whose place of residence is incompatible with close in-person follow-up consultations
- Woman of childbearing potential not using effective contraception
- Pregnant or breastfeeding woman
- Adult patient unable or unfit to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Background and Rationale:
Conventional mechanical implantation of total knee arthroplasty (TKA) aims to establish a lower-limb mechanical axis of 180°. Computer-assisted personalized implantation aims to restore a pre-arthritic alignment while respecting the soft-tissue envelope of the knee. Depending on design, TKA implants may either retain or sacrifice the posterior cruciate ligament (PCL). In mechanically implanted TKAs, functional outcomes of cruciate-retaining (CR) and posterior-stabilized (PS) designs are reported as comparable in the literature. However, these two designs have not been compared within a computer-assisted personalized implantation workflow. Objective and Hypothesis:
Read more
The objective of this randomized comparative study is to compare functional outcomes (patient-reported outcome measures - PROMs) at 24 months postoperatively following CR versus PS knee arthroplasty implanted with a personalized technique. The hypothesis is that there is no significant difference in functional outcomes between CR and PS prostheses implanted using a personalized technique. Study Design:
Single-center, open-label, randomized, two-arm parallel-group trial comparing a group of patients receiving a cruciate-retaining (CR) total knee prosthesis to a group receiving a posterior-stabilized (PS) total knee prosthesis.
Read the detailed description
Prior to hospitalization, the study will be proposed to patients by telephone 21 days before surgery. Following explanation of the study, answering patient questions, and obtaining oral agreement, the information leaflet will be sent by mail for review until hospitalization, when written informed consent is obtained. After signing consent, participants are randomized to either the CR or PS group. Preoperative Phase:Active joint range of motion measured using a goniometer. Completion of patient-reported questionnaires: Forgotten Joint Score (FJS-12), Knee Injury and Osteoarthritis Outcome Score (KOOS), Subjective Knee Value (SKV), and Net Promoter Score (NPS). Standard preoperative imaging (weight-bearing radiographs, skyline view, goniometry) to assess anatomical alignment and plan implant positioning. Intraoperative Phase:Navigation data and surgical characteristics will be documented on the Case Report Form (CRF), including:Surgical approach and necessity for PCL or collateral ligament release. Rates of conversion from CR to PS prosthesis. Initial and final HKA angle and flexion contracture. Femoral and tibial resection parameters (thickness, slopes, cut obliquities, rotation). Thickness of the implanted polyethylene insert. Postoperative Follow-up Phase (3, 12, and 24 months):Distribution and completion of follow-up PROMs (FJS-12, KOOS, SKV, NPS) during routine follow-up visits. Evaluation of knee joint range of motion (ROM) and clinical stability. Assessment and recording of audible knee clicking, patellar complications, and surgery-related adverse events (including revision, manipulation under anesthesia, or prosthetic loosening).
- Conditions
- Knee Arthroplasty, Osteoarthritis, Knee
- Being tested
- Implantation surgery for CR and PS knee-joint prostheses used in the orthopedic surgery department's routine practice
- Keywords
- Total Knee Arthroplasty, Cruciate-Retaining, Posterior-Stabilized, Posterior Cruciate Ligament, Personalized Implantation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation surgery for CR and PS knee-joint prostheses used in the orthopedic surgery department's routine practiceProcedure or surgery
The approach, the need for posterior cruciate ligament or collateral ligament release, the need to change from a CR to a PS prosthesis and the duration of the procedure will be recorded on the data collection sheet with the implantation and measurement characteristics performed with the navigator:
- HKA and initial and final flessums
- Tibial cuts: thickness (max), slope, obliquity of cut
- Femoral sections: distal and posterior thickness (max), mechanical femoral angle, rotation, femoral flessum, obliquity of cut.
- Thickness of implanted polyethylene
| Study group | Role | What they receive |
|---|---|---|
| A group of patients implanted with a knee prosthesis with preservation of the posterior cruciate (PC | Experimental | Not described Receives: Procedure: Implantation surgery for CR and PS knee-joint prostheses used in the orthopedic surgery department's routine practice |
| A group of patients implanted with a knee prosthesis without preservation of the posterior cruciate | Experimental | Not described Receives: Procedure: Implantation surgery for CR and PS knee-joint prostheses used in the orthopedic surgery department's routine practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forgotten Joint Score (FJS-12) at 24 Months Postoperatively
Patient-reported joint awareness and functional outcome assessed using the Forgotten Joint Score (FJS-12) questionnaire. The total score ranges from 0 to 100, where 0 represents the worst outcome (high joint awareness) and 100 represents the best possible outcome (complete forgetfulness of the artificial joint). Higher scores indicate better functional outcome and joint naturalness.
Measured: 24 months postoperatively
Secondary outcomes (9)
Change from Baseline in Knee Range of Motion (ROM)
Knee flexion and extension range of motion (measured in degrees using a goniometer) evaluated preoperatively and postoperatively.
Measured: Baseline (preoperative), 3 months, 12 months, and 24 months postoperatively
Incidence of Audible Knee Clicking
Percentage of patients reporting audible knee clicking during daily activities (excluding dynamic patellar clunk).
Measured: 3 months, 12 months, and 24 months postoperatively.
Rate of Patellar Complications
Proportion of patients presenting with patellar complications, including patellar crepitus, patellar clunk syndrome, patellar tilt > 20 degrees, or patellar dislocation.
Measured: Through 24 months postoperatively.
Intraoperative Surgical Navigation and Alignment Parameters
Measurement of surgical alignment and resection parameters using navigation, including initial/final HKA angle, initial/final flexion contracture, tibial/femoral cut thickness (mm), slopes and cut obliquities (degrees), polyethylene thickness (mm), PCL release rates in CR, CR-to-PS conversion rates, and peripheral ligament release.
Measured: Intraoperative (Day 0)
Incidence of Surgery-Related Major Adverse Events
Number of patients experiencing major surgical complications, defined as surgical revision, mobilization under general anesthesia, or prosthetic loosening.
Measured: Through 24 months postoperatively
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient-reported outcome evaluating knee function, symptoms, pain, daily living activities, sports/recreation, and quality of life. Each subscale score ranges from 0 to 100, where 0 represents extreme knee problems and 100 represents no knee problems. Higher scores indicate better knee function and fewer symptoms.
Measured: Baseline (preoperative), 3 months, 12 months, and 24 months postoperatively
Forgotten Joint Score (FJS-12) at 3 and 12 Months Postoperatively
Patient-reported joint awareness assessed using the FJS-12 questionnaire. Total score ranges from 0 to 100, where 0 represents the worst outcome and 100 represents the best possible outcome (higher scores indicate better outcome).
Measured: 3 months and 12 months postoperatively.
Subjective Knee Value (SKV) Score
Patient's self-assessment of their knee joint function as a percentage of a normal knee on a scale from 0% to 100%, where 0% represents a completely non-functional knee and 100% represents a fully normal knee. Higher scores indicate better joint function.
Measured: 3 months, 12 months, and 24 months postoperatively.
Net Promoter Score (NPS) for Patient Satisfaction
Single-item question assessing patient satisfaction and likelihood to recommend the surgical procedure to a friend or relative, rated on a scale from 0 ("not at all likely") to 10 ("extremely likely").
Measured: 3 months, 12 months, and 24 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start7 Mar 2024
- Primary completion2 Oct 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroplastyStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, open-label trial randomized in two parallel groups: A group of patients implanted with a knee prosthesis with preservation of the posterior cruciate ligament (CR). A group of patients implanted with a knee prosthesis without preservation of the posterior cruciate ligament (PS)
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon MARMOR, Orthopedic surgeon, Principal investigator, Groupe Hospitalier Diaconesses Croix Saint-Simon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757581
- Sponsor's protocol ID
- GHDCSS_SCAC2_CRPS_Ortho CRIOAC
- Other IDs
- 2023-A02516-39
- Acronym
- CR-PS
- Status last verified
- Aug 2026
- First submitted
- 6 May 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customized Knee Arthroplasty With or Without Posterior Cruciate Ligament Retention: A CR-PS Approach
- ClinicalTrials.gov ID
- NCT07757581
- Acronym / sponsor ID
- CR-PS / GHDCSS_SCAC2_CRPS_Ortho CRIOAC
- Conditions
- Knee Arthroplasty, Osteoarthritis, Knee
- Keywords
- Total Knee Arthroplasty, Cruciate-Retaining, Posterior-Stabilized, Posterior Cruciate Ligament, Personalized Implantation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 2 Oct 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 11 Aug 2026 (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.
Background and Rationale:
Conventional mechanical implantation of total knee arthroplasty (TKA) aims to establish a lower-limb mechanical axis of 180°. Computer-assisted personalized implantation aims to restore a pre-arthritic alignment while respecting the soft-tissue envelope of the knee. Depending on design, TKA implants may either retain or sacrifice the posterior cruciate ligament (PCL). In mechanically implanted TKAs, functional outcomes of cruciate-retaining (CR) and posterior-stabilized (PS) designs are reported as comparable in the literature. However, these two designs have not been compared within a computer-assisted personalized implantation workflow. Objective and Hypothesis:
The objective of this randomized comparative study is to compare functional outcomes (patient-reported outcome measures - PROMs) at 24 months postoperatively following CR versus PS knee arthroplasty implanted with a personalized technique. The hypothesis is that there is no significant difference in functional outcomes between CR and PS prostheses implanted using a personalized technique. Study Design:
Single-center, open-label, randomized, two-arm parallel-group trial comparing a group of patients receiving a cruciate-retaining (CR) total knee prosthesis to a group receiving a posterior-stabilized (PS) total knee prosthesis.
Detailed description
Prior to hospitalization, the study will be proposed to patients by telephone 21 days before surgery. Following explanation of the study, answering patient questions, and obtaining oral agreement, the information leaflet will be sent by mail for review until hospitalization, when written informed consent is obtained. After signing consent, participants are randomized to either the CR or PS group. Preoperative Phase:Active joint range of motion measured using a goniometer. Completion of patient-reported questionnaires: Forgotten Joint Score (FJS-12), Knee Injury and Osteoarthritis Outcome Score (KOOS), Subjective Knee Value (SKV), and Net Promoter Score (NPS). Standard preoperative imaging (weight-bearing radiographs, skyline view, goniometry) to assess anatomical alignment and plan implant positioning. Intraoperative Phase:Navigation data and surgical characteristics will be documented on the Case Report Form (CRF), including:Surgical approach and necessity for PCL or collateral ligament release. Rates of conversion from CR to PS prosthesis. Initial and final HKA angle and flexion contracture. Femoral and tibial resection parameters (thickness, slopes, cut obliquities, rotation). Thickness of the implanted polyethylene insert. Postoperative Follow-up Phase (3, 12, and 24 months):Distribution and completion of follow-up PROMs (FJS-12, KOOS, SKV, NPS) during routine follow-up visits. Evaluation of knee joint range of motion (ROM) and clinical stability. Assessment and recording of audible knee clicking, patellar complications, and surgery-related adverse events (including revision, manipulation under anesthesia, or prosthetic loosening).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, open-label trial randomized in two parallel groups: A group of patients implanted with a knee prosthesis with preservation of the posterior cruciate ligament (CR). A group of patients implanted with a knee prosthesis without preservation of the posterior cruciate ligament (PS)
| Arm | Type | Receives |
|---|---|---|
| A group of patients implanted with a knee prosthesis with preservation of the posterior cruciate (PC | Experimental | Procedure: Implantation surgery for CR and PS knee-joint prostheses used in the orthopedic surgery department's routine practice |
| A group of patients implanted with a knee prosthesis without preservation of the posterior cruciate | Experimental | Procedure: Implantation surgery for CR and PS knee-joint prostheses used in the orthopedic surgery department's routine practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient information provided and signed written informed consent obtained in duplicate
- Male and female participants aged 18 years or older
- Primary total knee arthroplasty for knee osteoarthritis performed in the orthopaedic surgery department
Key exclusion criteria (12 listed)
- History of posterior cruciate ligament (PCL) rupture or prior ligamentoplasty
- History of ipsilateral femur or tibia fracture
- Coronal plane axial deviation greater than 15 degrees (HKA < 165° or > 195°)
- Flexion contracture (flexum) greater than 15 degrees
- Tibial slope greater than 10 degrees
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 |
|---|---|---|
| Implantation surgery for CR and PS knee-joint prostheses used in the orthopedic surgery department's routine practiceThe approach, the need for posterior cruciate ligament or collateral ligament release, the need to change from a CR to a PS prosthesis and the duration of the procedure will be recorded on the data collection sheet with the implantation and measurement characteristics performed with the navigator: * HKA and initial and final flessums * Tibial cuts: thickness (max), slope, obliquity of cut * Femoral sections: distal and posterior thickness (max), mechanical femoral angle, rotation, femoral flessum, obliquity of cut. * Thickness of implanted polyethylene | Procedure or surgery | A group of patients implanted with a knee prosthesis with preservation of the posterior cruciate (PC, A group of patients implanted with a knee prosthesis without preservation of the posterior cruciate |
Primary outcome
Forgotten Joint Score (FJS-12) at 24 Months Postoperatively
Time frame: 24 months postoperatively
Patient-reported joint awareness and functional outcome assessed using the Forgotten Joint Score (FJS-12) questionnaire. The total score ranges from 0 to 100, where 0 represents the worst outcome (high joint awareness) and 100 represents the best possible outcome (complete forgetfulness of the artificial joint). Higher scores indicate better functional outcome and joint naturalness.
9 secondary outcomes
Change from Baseline in Knee Range of Motion (ROM)
Time frame: Baseline (preoperative), 3 months, 12 months, and 24 months postoperatively
Incidence of Audible Knee Clicking
Time frame: 3 months, 12 months, and 24 months postoperatively.
Rate of Patellar Complications
Time frame: Through 24 months postoperatively.
Intraoperative Surgical Navigation and Alignment Parameters
Time frame: Intraoperative (Day 0)
Incidence of Surgery-Related Major Adverse Events
Time frame: Through 24 months postoperatively
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline (preoperative), 3 months, 12 months, and 24 months postoperatively
Forgotten Joint Score (FJS-12) at 3 and 12 Months Postoperatively
Time frame: 3 months and 12 months postoperatively.
Subjective Knee Value (SKV) Score
Time frame: 3 months, 12 months, and 24 months postoperatively.
Net Promoter Score (NPS) for Patient Satisfaction
Time frame: 3 months, 12 months, and 24 months postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Simon MARMOR, Orthopedic surgeon principal investigator
Groupe Hospitalier Diaconesses Croix Saint-Simon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation surgery for CR and PS knee-joint prostheses used in the orthopedic surgery department's routine practice in people with Knee Arthroplasty and Osteoarthritis, Knee, run by Groupe Hospitalier Diaconesses Croix Saint-Simon 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 12 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Forgotten Joint Score (FJS-12) at 24 Months Postoperatively (time frame: 24 months postoperatively). 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 11 Aug 2026.