Knee SurgeryNCT06207968
FH ORTHO SAS Knee Observatory
An observational study of Knee Surgery, run by FH ORTHO at 10 sites in France.
Trial summary
The objective of this observatory is to generate additional real life clinical data in accordance with local regulation (i.e. Post-Market Clinical Follow-up (PMCF) study, a study carried out following the European Conformity (CE) marking of a device and intended to answer specific questions relating to clinical safety… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Surgery
- What is being tested?
- Knee surgery with FH Ortho devices
- Type of treatment
- Medical device
- How many people
- 487 participants
- Where
- 10 sitesFrance
- Study dates
- May 2024to Jun 2044
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The patient population will be representative of the target population of the medical devices. The aim is to recruit in the first 3 years in 15-20 sites in France, 487 patients who have benefited from knee arthroplasty or ligament reconstruction of the knee. Arthroplasty arm: Knee prostheses are intended for patients suffering from functionally serious diseases of the knee causing daily disability that is insufficiently improved by medical treatment (Knee osteoarthrosis, Osteonecrosis of the knee, Inflammatory disease, or Patellofemoral arthritis). Ligament reconstruction arm: Ligament reconstruction surgery should be considered for patient who have undergone a rupture of the anterior and/or posterior cruciate ligaments requiring partial or total reconstruction.
Who may be able to join
- Any patient undergoing or having undergone implantation of medical devices distributed by FH ORTHO SAS for knee arthroplasty and ligament reconstruction, used in accordance with their approved IFU, in one of the centers participating in the Observatory.
- Patient is at least 18 years old at the time of surgery
- Patient agreeing to participate after having been informed orally and in writing (with written consent if required locally)
- In some countries, such as France, the patient will have to be socially insured to be included in the study.
Who cannot join
- For Arthroplasty:
- Infection, or latent infection
- A mental or neuromuscular disorder that might create an unacceptable risk of instability, prosthetic fixation failure, or complications after surgery
- Insufficient bone stock for proper implant fixation
- It is the surgeon's responsibility to make sure that the patient does not have any known allergies to one of the compounds of the material listed on the product label.
- Metabolic diseases that might compromise bone regrowth
Show all 16Show fewer
- Drug addiction
- Incomplete bone growth
- For Ligament reconstruction:
- Infection, or latent infection
- A mental or neuromuscular disorder that might create an unacceptable risk of instability, prosthetic fixation failure, or complications after surgery
- Insufficient bone stock
- Known allergies to one of the compounds of the material listed on the product label.
- Metabolic diseases that might compromise bone regrowth
- Uncooperative patient unable to follow recommendations
- As the medical devices are used in real life according to their indications, pregnant or breastfeeding women are not excluded from the study, but for safety reasons it is not advisable to include them in the study.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites
Clinique De La Chataigneraie
Beaumont, 63541
Charles CASIN, MD, charles.casin@yahoo.fr
Charles CASIN, MD
Clinique De La Miotte
Belfort, 90002
Pierre Bastien REY, MD, docteur.rey@docteur-rey.fr
Pierre Bastien REY, MD
Polyclinique St Privat
Boujan-sur-Libron, 34760
Guillaume MIROUSE, MD, gmirouse@gmail.com
Guillaume MIROUSE, MD
Clinique Du Val D'Ouest
Écully, 69130
Benoit GIRAUD, MD, dr.jgiraud@wanadoo.fr
Benoit GIRAUD, MD
C.H. Raymond Poincare
Garches, 92380
Hôpital Saint Vincent de Paul
Lille, 59000
Jean-Claude BOU, MD, bou.jean-claude@ghicl.net
Jean-Claude BOU, MD
Hôpital Prive St Grégoire
Saint-Grégoire, 35768
Charles Kajetanek, MD, charles.kajetanek@gmail.com
Charles Kajetanek, MD
Polyclinique De L'Europe
Saint-Nazaire, 44615
Xavier CLÉMENT, MD, xavclement@hotmail.fr
Xavier CLÉMENT, MD
Medipole Garonne
Toulouse, 31036
Rodolphe LIMOZIN, MD, rodolphe@limozin.net
Rodolphe LIMOZIN, MD
Hôpital Privé Océane
Vannes, 56000
About this study
Official title: Post Market Clinical Follow-up of Knee Surgery Using FH ORTHO SAS Medical Devices (FH ORTHO SAS Knee Observatory)
The objective of this observatory is to generate additional real life clinical data in accordance with local regulation (i.e. Post-Market Clinical Follow-up (PMCF) study, a study carried out following the European Conformity (CE) marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a device when used in accordance with its approved instructions for use (IFU).
The difficulty of such an observatory is to be able to collect data on the different versions of the devices, on the different possible combinations of implants of an knee arthroplasty. The observatory must also be able to cover devices used in ligament reconstruction surgery.
Read more
The observatory will be based on the principle of a "dynamic" cohort during the inclusion period, i.e. with possible inclusions to replace the premature exits.
Technical solutions will be implemented to facilitate data collection from surgeons (electronic Case Report Form (eCRF) and from patients (Electronic Patient Reported Outcome (ePRO) on smartphone/tablet/computer) when feasible.
The data to be collected and the different follow-up times are based on our state-of-the-art, clinical evaluation plans and clinical evaluation reports.
Read the detailed description
PMCF as part of CE mark renewal, to answer questions related to the safety and clinical performance of the devices, when used according to their approved instructions for use.
This is an European, prospective and retrospective, multicenter, non-comparative study.
Randomization is considered impossible due to surgeon preference, anatomical conditions and other patient factors, and the use of different techniques.
This observatory is non-comparative, due to the absence of a gold standard and the technical, logistical and contractual constraints involved.
This PMCF study (CE-marked MD, any class, used as intended) provide additional non-burdensome and non-invasive procedures.
The Observatory will therefore be based on the principle of a "dynamic" cohort, i.e. with possible exits and inclusions throughout the Observatory period.
The aim of this methodology is to have a sufficient number of patients to be able to carry out descriptive statistical analyses each year, and to be able to calculate the evaluation criteria with the longest possible follow-up of results. Data will be collected before surgery, during surgery and at follow-up visits. Data collection will focus on obtaining short- and long-term data for performance and safety evaluation (up to 20 years for knee arthroplasty prostheses; up to 5 years for knee ligament reconstruction devices). In the case of knee arthroplasty, it is recommended to have performance and safety data at 1, 2, 5 and 10 years of follow-up, as well as safety data at 15 and 20 years if possible. In the case of ligament reconstruction, it is recommended to have performance and safety data at 1 and 2 years, as well as safety data at 5 years. The platform will be able to send automatic notifications to surgeons to remind them of scheduled patient follow-ups, missing data, and encourage them to include new patients if necessary. Self-questionnaires will be completed by patients via a web-based platform, available on computer or smartphone/tablet. Alternatively, patients will complete paper self-questionnaires, which will then be entered into the database by the investigating team.
It will also be possible to arrange for direct telephone contact with patients by an independent structure guaranteeing non-dissemination of nominative data (e.g. CRO). Telephone contact can also be made if the patient is geographically remote or has difficulty travelling. Patient recruitment: Continuous, consecutive, prospective and retrospective (for some implants because few implants have been used for this condition) recruitment to guarantee a minimum number of patients per type of device. Individual written information for each patient will be mandatory. A signed patient consent form will be required in Europe, after sufficient time for reflection.
- Conditions
- Knee Surgery
- Being tested
- Knee surgery with FH Ortho devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee surgery with FH Ortho devicesDevice
This clinical investigation is a real-life observatory designed to collect long-term clinical data on patients who have undergone knee joint replacement or knee ligament reconstruction.
In this type of intervention, one or more medical devices distributed by FH ORTHO SAS may be used by surgeons.
| Study group | Role | What they receive |
|---|---|---|
| Arthroplasty | Knee prostheses are intended for patients suffering from functionally serious diseases of the knee causing daily disability that is insufficiently improved by medical treatment.
The functional diseases are among:
* Knee osteoarthrosis
* Osteonecrosis of the knee
* Inflammatory disease
* Patellofemoral arthritis
The patients having benefited from an arthroplasty will be followed for at least 15 years (until 20 years). Receives: Device: Knee surgery with FH Ortho devices | |
| Ligament reconstruction | Ligament reconstruction surgery should be considered for patient who have undergone a rupture of the anterior and/or posterior cruciate ligaments requiring partial or total reconstruction.
The patients having benefited from a ligament reconstruction will be followed for at least 5 years. Receives: Device: Knee surgery with FH Ortho devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision rate
Evaluate the revision rate at the longest follow-up possible for arthroplasty arm
Measured: 2 months, 3-6 months, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years
Revision rate
Evaluate the revision rate at the longest follow-up possible for ligament reconstruction arm
Measured: 2 months, 3-6 months, 1 year, 2 years, 5 years
Secondary outcomes (10)
International Knee Society (IKS 2011) score
Mobility, Pain and Function for Arthroplasty arm.
It includes a 100-point objective score and a subjective score made up of 3 domains evaluating satisfaction on 40 points, patient expectations on 15 points using different items between the pre- and post-operative phases, as well as functional activities on 100 points. The total score was 255 points. There are no levels and the results are expressed as raw scores. Higher scores mean a better outcome.
Measured: Pre-operative, 3-6months, 1 year, 2 years, 5 years, 10 years
Complications/Adverse events
any adverse events leading or not to re-intervention (with or without change of the implant), including device malfunctions
Measured: During surgery, Immediate (0-2months), 3-6months, 1 year, 2 years, 5 years, 10 years
International Knee Documentation Committee (IKDC 2000) score
Mobility, Pain and Function for Ligament Reconstruction arm
This self-questionnaire is divided into three parts (symptoms, sporting activities, function) and gives a score between 0 (worst) and 100 (best). This score is interpreted as a measure of functional capacity, with the highest scores representing the best levels of function and the lowest levels representing symptoms. A score of 100 means that there are no limits to daily activities and sports and that symptoms are non-existent.
Measured: Pre-operative, 1 year, 2 years
Lysholm Knee Scoring Scale
Mobility, Pain and Function for Ligament Reconstruction arm The Lysholm Knee Score is a questionnaire that the patient completes with the therapist. The questionnaire is designed to assess the degree of knee instability, in terms of both impairment and limitation.
The Lysholm Knee Score calculates and rates an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, weight bearing, instability and oedema. Doctors use this condition-specific subjective outcome score to assess a patient's progress after knee surgery or injury. Scores between 95 and 100 are considered exceptional, those between 84 and 94 acceptable, those between 65 and 83 fair and those below 65 poor.
Measured: Pre-operative, 1 year, 2 years
Tegner activity level scale
Mobility, Pain and Function for Ligament Reconstruction arm
The Tegner activity scale is a numerical scale with values ranging from 0 to 10, each representing a different activity. A person is considered to have an activity level of 10 if they play highly competitive sports such as rugby, football and soccer. A person who plays the above sports recreationally is considered to have an activity level of 6. A person with knee problems who is on sick leave or receiving a disability pension is considered to have an activity level of 0.
Measured: Pre-operative, 1 year, 2 years
Knee laxity (clinical section)
Mobility, Pain and Function for Ligament Reconstruction arm.
This questionnaire is completed by the physician. He will assessed laxity of operated knee, as:
Pivot Shift test: absent (0), grade 1 (+), grade 2 (++), grade 3 (+++).
Measured: Pre-operative, 3-6 months
Complications/Adverse events
Any adverse events leading or not to re-intervention (with or without change of the implant), including device malfunctions
Measured: During surgery, Immediate (0-2months), 3-6months, 1 year, 2 years, 5 years
Visual Analogue Scale (VAS)
for arthroplasty arm Pain rating scale. A straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the pain to be measured orientated from the left (worst) to the right (best).
The scale is given to the patient during the consultation, the patient indicates his/her level of pain and the surgeon then transcribes the score.
Measured: 1 year, 2 years, 5 years, 10 years, 15 years, 20 years
Visual Analogue Scale (VAS)
for ligament reconstruction arm Pain rating scale. A straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the pain to be measured orientated from the left (worst) to the right (best).
The scale is given to the patient during the consultation, the patient indicates his/her level of pain and the surgeon then transcribes the score.
Measured: 1 year, 2 years, 5 years
ASA (American Society of Anesthesiologists)-score
The American Society of Anesthesiologists proposes five classes of patients requiring anaesthesia.
Class 1: patient in good health. Class 2: patient with moderate general illness. Class 3: patient with a serious but not incapacitating general illness. Class 4: patient with a life-threatening general illness. Class 5: a moribund patient who would not survive 24 hours without the procedure, the outcome of which is uncertain.
Measured: Pre-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study startMay 2024 (estimated)
- Primary completionJun 2044 (estimated)
- Study completionJun 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 487 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FH ORTHO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles KAJETANEK, MD, Principal investigator, Hôpitaux Privés Rennais - Saint-Grégoire (Vivalto Santé) Institut Locomoteur de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207968
- Sponsor's protocol ID
- 2021-02
- Status last verified
- Feb 2024
- First submitted
- 19 Dec 2023
- Last updated
- 22 Feb 2024
- 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 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-up of Knee Surgery Using FH ORTHO SAS Medical Devices (FH ORTHO SAS Knee Observatory)
- ClinicalTrials.gov ID
- NCT06207968
- Acronym / sponsor ID
- 2021-02
- Conditions
- Knee Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 487 participants (estimated)
- Lead sponsor
- FH ORTHOIndustry (pharma, biotech, devices)
- Study start
- May 2024 (estimated)
- Primary completion
- Jun 2044 (estimated)
- Study completion
- Jun 2044 (estimated)
- First posted
- 17 Jan 2024 (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 objective of this observatory is to generate additional real life clinical data in accordance with local regulation (i.e. Post-Market Clinical Follow-up (PMCF) study, a study carried out following the European Conformity (CE) marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a device when used in accordance with its approved instructions for use (IFU).
The difficulty of such an observatory is to be able to collect data on the different versions of the devices, on the different possible combinations of implants of an knee arthroplasty. The observatory must also be able to cover devices used in ligament reconstruction surgery.
The observatory will be based on the principle of a "dynamic" cohort during the inclusion period, i.e. with possible inclusions to replace the premature exits.
Technical solutions will be implemented to facilitate data collection from surgeons (electronic Case Report Form (eCRF) and from patients (Electronic Patient Reported Outcome (ePRO) on smartphone/tablet/computer) when feasible.
The data to be collected and the different follow-up times are based on our state-of-the-art, clinical evaluation plans and clinical evaluation reports.
Detailed description
PMCF as part of CE mark renewal, to answer questions related to the safety and clinical performance of the devices, when used according to their approved instructions for use.
This is an European, prospective and retrospective, multicenter, non-comparative study.
Randomization is considered impossible due to surgeon preference, anatomical conditions and other patient factors, and the use of different techniques.
This observatory is non-comparative, due to the absence of a gold standard and the technical, logistical and contractual constraints involved.
This PMCF study (CE-marked MD, any class, used as intended) provide additional non-burdensome and non-invasive procedures.
The Observatory will therefore be based on the principle of a "dynamic" cohort, i.e. with possible exits and inclusions throughout the Observatory period.
The aim of this methodology is to have a sufficient number of patients to be able to carry out descriptive statistical analyses each year, and to be able to calculate the evaluation criteria with the longest possible follow-up of results. Data will be collected before surgery, during surgery and at follow-up visits. Data collection will focus on obtaining short- and long-term data for performance and safety evaluation (up to 20 years for knee arthroplasty prostheses; up to 5 years for knee ligament reconstruction devices). In the case of knee arthroplasty, it is recommended to have performance and safety data at 1, 2, 5 and 10 years of follow-up, as well as safety data at 15 and 20 years if possible. In the case of ligament reconstruction, it is recommended to have performance and safety data at 1 and 2 years, as well as safety data at 5 years. The platform will be able to send automatic notifications to surgeons to remind them of scheduled patient follow-ups, missing data, and encourage them to include new patients if necessary. Self-questionnaires will be completed by patients via a web-based platform, available on computer or smartphone/tablet. Alternatively, patients will complete paper self-questionnaires, which will then be entered into the database by the investigating team.
It will also be possible to arrange for direct telephone contact with patients by an independent structure guaranteeing non-dissemination of nominative data (e.g. CRO). Telephone contact can also be made if the patient is geographically remote or has difficulty travelling. Patient recruitment: Continuous, consecutive, prospective and retrospective (for some implants because few implants have been used for this condition) recruitment to guarantee a minimum number of patients per type of device. Individual written information for each patient will be mandatory. A signed patient consent form will be required in Europe, after sufficient time for reflection.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroplasty | – | Device: Knee surgery with FH Ortho devicesKnee prostheses are intended for patients suffering from functionally serious diseases of the knee causing daily disability that is insufficiently improved by medical treatment. The functional diseases are among: * Knee osteoarthrosis * Osteonecrosis of the knee * Inflammatory disease * Patellofemoral arthritis The patients having benefited from an arthroplasty will be followed for at least 15 years (until 20 years). |
| Ligament reconstruction | – | Device: Knee surgery with FH Ortho devicesLigament reconstruction surgery should be considered for patient who have undergone a rupture of the anterior and/or posterior cruciate ligaments requiring partial or total reconstruction. The patients having benefited from a ligament reconstruction will be followed for at least 5 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population will be representative of the target population of the medical devices. The aim is to recruit in the first 3 years in 15-20 sites in France, 487 patients who have benefited from knee arthroplasty or ligament reconstruction of the knee. Arthroplasty arm: Knee prostheses are intended for patients suffering from functionally serious diseases of the knee causing daily disability that is insufficiently improved by medical treatment (Knee osteoarthrosis, Osteonecrosis of the knee, Inflammatory disease, or Patellofemoral arthritis). Ligament reconstruction arm: Ligament reconstruction surgery should be considered for patient who have undergone a rupture of the anterior and/or posterior cruciate ligaments requiring partial or total reconstruction.
Key inclusion criteria (4 listed)
- Any patient undergoing or having undergone implantation of medical devices distributed by FH ORTHO SAS for knee arthroplasty and ligament reconstruction, used in accordance with their approved IFU, in one of the centers participating in the Observatory.
- Patient is at least 18 years old at the time of surgery
- Patient agreeing to participate after having been informed orally and in writing (with written consent if required locally)
- In some countries, such as France, the patient will have to be socially insured to be included in the study.
Key exclusion criteria (16 listed)
- Infection, or latent infection
- A mental or neuromuscular disorder that might create an unacceptable risk of instability, prosthetic fixation failure, or complications after surgery
- Insufficient bone stock for proper implant fixation
- It is the surgeon's responsibility to make sure that the patient does not have any known allergies to one of the compounds of the material listed on the product label.
- Metabolic diseases that might compromise bone regrowth
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 |
|---|---|---|
| Knee surgery with FH Ortho devicesThis clinical investigation is a real-life observatory designed to collect long-term clinical data on patients who have undergone knee joint replacement or knee ligament reconstruction. In this type of intervention, one or more medical devices distributed by FH ORTHO SAS may be used by surgeons. | Device | Arthroplasty, Ligament reconstruction |
Primary outcome
Revision rate
Time frame: 2 months, 3-6 months, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years
Evaluate the revision rate at the longest follow-up possible for arthroplasty arm
Revision rate
Time frame: 2 months, 3-6 months, 1 year, 2 years, 5 years
Evaluate the revision rate at the longest follow-up possible for ligament reconstruction arm
10 secondary outcomes
International Knee Society (IKS 2011) score
Time frame: Pre-operative, 3-6months, 1 year, 2 years, 5 years, 10 years
Complications/Adverse events
Time frame: During surgery, Immediate (0-2months), 3-6months, 1 year, 2 years, 5 years, 10 years
International Knee Documentation Committee (IKDC 2000) score
Time frame: Pre-operative, 1 year, 2 years
Lysholm Knee Scoring Scale
Time frame: Pre-operative, 1 year, 2 years
Tegner activity level scale
Time frame: Pre-operative, 1 year, 2 years
Knee laxity (clinical section)
Time frame: Pre-operative, 3-6 months
Complications/Adverse events
Time frame: During surgery, Immediate (0-2months), 3-6months, 1 year, 2 years, 5 years
Visual Analogue Scale (VAS)
Time frame: 1 year, 2 years, 5 years, 10 years, 15 years, 20 years
Visual Analogue Scale (VAS)
Time frame: 1 year, 2 years, 5 years
ASA (American Society of Anesthesiologists)-score
Time frame: Pre-operative
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 22 Feb 2024.
- Individual participant dataSharing planned: No
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Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection
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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.
Charles KAJETANEK, MD principal investigator
Hôpitaux Privés Rennais - Saint-Grégoire (Vivalto Santé) Institut Locomoteur de l'Ouest
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Surgery, run by FH ORTHO at 10 sites 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 16 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: opening soon, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 Cindy Lai (631315494 ext. +33, c.lai@fhortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revision rate (time frame: 2 months, 3-6 months, 1 year, 2 years, 5 years, 10 years, 15 years, 20 years). The study lists 2 primary outcomes in all. 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 22 Feb 2024.