Hip OsteoarthritisPTG-AnatomicNCT07313449
Study of the Clinical and Radiographic Results of a Fixed Polyethylene Posteriorly Stabilized Cemented Total Knee Prosthesis With a Minimum Follow-up of 1 Year.
An observational study of Hip Osteoarthritis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The knee replacement market is experiencing constant growth. Alongside this growth, there is also an increasing interest in customizing implantation based on specific phenotypes to restore the morphology of the native knee. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis
- How many people
- 960 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2025to Feb 2026
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Adult patient who underwent total knee replacement (TKR) between January 2013 and December 2024 - Patient who underwent an Anatomic, Amplitude, posteriorly stabilized, fixed polyethylene, cemented TKR
Who may be able to join
- Adult patient
- Patient who underwent total knee replacement (TKR) between January 2013 and December 2024
- Patient who underwent an Anatomic, Amplitude, posteriorly stabilized, fixed polyethylene, cemented TKR
- Patient operated on by Professor F. Bonnomet
- Available radiological data: preoperative, immediate postoperative, and postoperative at a minimum of 1 year follow-up
Who cannot join
- Revision of the arthroplasty during the study follow-up period for a cause not investigated in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Orthopédique et de Traumatologie du Membre Inférieur - CHU de Strasbourg - France
Strasbourg, 67091
François BONNOMET, MD, PhD, 33 3 68 76 52 82, Francois.bonnomet@chru-strasbourg.fr
François BONNOMET, MD, PhD
About this study
The knee replacement market is experiencing constant growth. Alongside this growth, there is also an increasing interest in customizing implantation based on specific phenotypes to restore the morphology of the native knee. For example, in the last five years, 2019 publications on knee prosthesis alignment have been identified on PubMed.
It seems worthwhile to study and analyze the performance of the prosthesis used in the Orthopedic Surgery Department of the Strasbourg University Hospitals (HUS) and to compare it with results from the literature.
- Conditions
- Hip Osteoarthritis
- Keywords
- Osteonecrosis, Hip Osteoarthritis
- Medical subject headings
- Osteoarthritis, Hip, Osteonecrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
IKS / KSS (Knee Society Score)
The classic IKS (often called KSS) has 2 separate scores, each out of 100 points:
- Knee Score (Objective / Clinical) - 0 to 100 Assesses the knee itself:
- Pain (0-50)
- Range of motion (0-25)
- Stability (0-25)
- Function Score - 0 to 100
- Assesses patient function:
- Walking distance (0-50)
- Stair climbing (0-50)
Interpretation (commonly used):
- 80-100: Excellent
- 70-79: Good
- 60-69: Fair
- < 60: Poor
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start31 Jan 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313449
- Sponsor's protocol ID
- 9534
- Acronym
- PTG-Anatomic
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Clinical and Radiographic Results of a Fixed Polyethylene Posteriorly Stabilized Cemented Total Knee Prosthesis With a Minimum Follow-up of 1 Year.
- ClinicalTrials.gov ID
- NCT07313449
- Acronym / sponsor ID
- PTG-Anatomic / 9534
- Conditions
- Hip Osteoarthritis
- Keywords
- Osteonecrosis, Hip Osteoarthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 2 Jan 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.
The knee replacement market is experiencing constant growth. Alongside this growth, there is also an increasing interest in customizing implantation based on specific phenotypes to restore the morphology of the native knee. For example, in the last five years, 2019 publications on knee prosthesis alignment have been identified on PubMed.
It seems worthwhile to study and analyze the performance of the prosthesis used in the Orthopedic Surgery Department of the Strasbourg University Hospitals (HUS) and to compare it with results from the literature.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient who underwent total knee replacement (TKR) between January 2013 and December 2024 - Patient who underwent an Anatomic, Amplitude, posteriorly stabilized, fixed polyethylene, cemented TKR
Key inclusion criteria (5 listed)
- Adult patient
- Patient who underwent total knee replacement (TKR) between January 2013 and December 2024
- Patient who underwent an Anatomic, Amplitude, posteriorly stabilized, fixed polyethylene, cemented TKR
- Patient operated on by Professor F. Bonnomet
- Available radiological data: preoperative, immediate postoperative, and postoperative at a minimum of 1 year follow-up
Key exclusion criteria (1 listed)
- Revision of the arthroplasty during the study follow-up period for a cause not investigated in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IKS / KSS (Knee Society Score)
Time frame: Up to 12 months
The classic IKS (often called KSS) has 2 separate scores, each out of 100 points: 1. Knee Score (Objective / Clinical) - 0 to 100 Assesses the knee itself: * Pain (0-50) * Range of motion (0-25) * Stability (0-25) 2. Function Score - 0 to 100 * Assesses patient function: * Walking distance (0-50) * Stair climbing (0-50) Interpretation (commonly used): * 80-100: Excellent * 70-79: Good * 60-69: Fair * < 60: Poor
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 2 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Osteoarthritis, run by University Hospital, Strasbourg, France 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 2 Jan 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?
Contact François BONNOMET, MD, PhD (33 3 68 76 52 82, Francois.bonnomet@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IKS / KSS (Knee Society Score) (time frame: Up to 12 months). 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 2 Jan 2026.