Prosthesis SurvivalNCT04244929
Multicenter Perspective Study: Clinical Evaluation of the Persona MC® With Preservation or Sacrifice of the PCL
A study testing Total knee arthroplasty, Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament retaining and Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament sacrifice in people with Prosthesis Survival, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Prospective, multicenter study on the Total Knee Prosthesis available on the market "Persona Medial Congruent® knee". Primary endpoint -Evaluation of the survival of the implant after 5 years of follow-up Secondary endpoints Evaluation of the survival of the implant at 10 years of follow up. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prosthesis Survival
- What is being tested?
- Total knee arthroplasty, Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament retaining and Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament sacrifice
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteItaly
- Study dates
- 20 Dec 2019to 1 Mar 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient qualifies for a primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis
- Collagen disorders and/or avascular necrosis of the femoral condyle
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
- Moderate valgus, varus, or flexion deformities
- The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee
Show all 9Show fewer
- Patient is willing and able to complete scheduled study procedures and follow-up evaluations
- Independent of study participation, patient is a candidate for commercially available Persona MC knee implants. Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
- Patient has participated in the Informed Consent process and has signed the Ethics Committee approved 'Informed Consent'.
Who cannot join
- Patient is currently participating in any other surgical intervention studies or pain management studies
- Patient is unwilling or unable to give consent or to comply with the follow-up program.
- Patient meets exclusion criteria of the Instruction for Use Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them.
- Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
- Insufficient bone stock on femoral or tibial surfaces
- Skeletal immaturity
Show all 12Show fewer
- Neuropathic arthropathy
- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
- Stable, painless arthrodesis in a satisfactory functional position
- Severe instability secondary to the absence of collateral ligament integrity
- Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
- Patient has a known or suspected sensitivity or allergy to one or more of the implant materials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Total Knee Prosthesis Persona Medial Congruent® With Preservation or Sacrifice of the Posterior Cruciate Ligament: a Multicentric Perspective Study
Prospective, multicenter study on the Total Knee Prosthesis available on the market "Persona Medial Congruent® knee".
Primary endpoint
-Evaluation of the survival of the implant after 5 years of follow-up
Secondary endpoints
- Evaluation of the survival of the implant at 10 years of follow up.
- Evaluation of clinical and radiographic outcomes in Italian patients undergoing total knee replacement with the Persona Medial Congruent® implant with sacrifice or retention of the posterior cruciate ligament (PCL)
Read the detailed description
Prospective, multicenter study on the Total Knee Prosthesis available on the market "Persona Medial Congruent® knee" Up to 10 Italian centers will provide a maximum of 200 patients undergoing total knee replacement with Persona prosthesis and Medial Congruent® insert.
20 cases per center will be performed, 10 with posterior cruciate ligament sacrifice, 10 with posterior cruciate ligament preservation.
Patients will be recruited and enrolled in the study according to the inclusion and exclusion criteria specified below. In order to minimize the selection bias, patients will be enrolled consecutively; the first 10 patients will constitute a treatment group and the remaining 10 the complementary group.
Each patient will sign an informed consent for participation in the prospective study. The patients will be recruited at the Orthopedic and Traumatological Clinic 2nd of the Rizzoli Orthopedic Institute on an outpatient or hospitalization basis.
After the surgical treatment, the patient will continue his hospitalization at the Orthopedic and Traumatological Clinic 2nd of the Rizzoli Orthopedic Institute and, if deemed appropriate by the medical team, he will be discharged by planning the subsequent post-operative checks and diagnostic evaluations.
The data will be collected by investigators and provided to the Promoter center.
The Co-investigator who will evaluate the results will be blind to the assignment to the treatment group of the subjects in the study. The promoter of the study is the owner of the data and therefore responsible for data management. Study participants are identified with an identification code. All sensitive personal data will be stored in accordance with the current data privacy guidelines. All information will be treated with strict compliance with professional confidentiality standards. Participants will receive oral and written information relating to the processing of sensitive personal data.
The study is designed to have an alpha error of no more than 0.05. Based on an assumed 95% five-year survival, a sample size of n = 89 was calculated using SAS 9.4, Proc Power.
Assuming a 20% follow-up loss rate over five years, the study will enroll 100 patients in each patient group, then a total of 200 patients. The data collected from 200 patients (100 in each subgroup) will be archived in a descriptive way and will be the basis of all published study reports.
The categorical data (for example, gender) will be summarized using counts, percentages and the 95% confidence interval (CI), in the periods of interest. Continuous data, such as age, will be summarized using means, medians, standard deviation, minimum, maximum and 95% CI in the periods of interest. Implant survival and return to function will be summarized using the Kaplan-Meier method and presented as percentages and confidence intervals.
The expected duration of the study is 11 years, which corresponds to the time dedicated to the approval of the Ethics Committee, the enrollment of all patients, the completion of the 10-year follow-up, data analysis and preparation of the final report. The first 12 months will focus on patient enrollment. The study subjects will be involved from the moment of the intervention until the end of the 10-year follow-up (as per the current protocol 10 years FU ± 2 months).
- Conditions
- Prosthesis Survival
- Being tested
- Total knee arthroplasty, Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament retaining, Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament sacrifice
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
Total knee arthroplasty using standard anterior approach.
Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament retainingDevice
Patients will be implanted with this medial pivoting knee prosthesis. Posterior Cruciate Ligament will be retained
Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament sacrificeDevice
Patients will be implanted with this medial pivoting knee prosthesis. Posterior Cruciate Ligament will be sacrificed
| Study group | Role | What they receive |
|---|---|---|
| PCL removal | Experimental | Patients will undergo surgery by sacrificing the PCL Receives: Procedure: Total knee arthroplasty; Device: Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament sacrifice |
| PCL preservation | Active comparator | Patients will undergo surgery with retaining the PCL Receives: Procedure: Total knee arthroplasty; Device: Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament retaining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety based on implant survivorship at 5 years follow up
Implant survival will be evaluated by radiographic parameters on standard and long leg standing radiographs that indicate prosthesis mobilization (radiolucency lines, fracture, osteolysis)
Measured: 72 months
Secondary outcomes (12)
Evaluate the safety based on implant survivorship at 10 years follow up
Implant survival will be evaluated by radiographic parameters on standard and long leg standing radiographs that indicate prosthesis mobilization (radiolucency lines, fracture, osteolysis)
Measured: 132 months
Evaluation of pain
Clinical evaluation addresses the state of the studied knee before and after the surgery with respect to pain (VAS scale).
Measured: 132 months
Evaluation of medication taken by the patient
Clinical evaluation addresses the state of the studied knee before and after the surgery with respect to medications.
Measured: 132 months
Evaluation of muscle strength
Clinical evaluation addresses the state of the studied knee before and after the surgery with respect to muscle strength, evaluated with a subjective scale by the investigator
Measured: 132 months
Return to work
Additional information regarding the returning of the patient to work is collected at 3 or 6 months follow up
Measured: 132 months
Patient Satisfaction Questionnaire
It is a patient-reported short questionnaire for evaluating patient satisfaction with the knee replacement surgery
Measured: 132 months
Euro Quality of Life-5 Dimensions-5 Levels Health Questionnaire
It is completed by the patient and assesses his/her general health status. The EQ-5D is used to derive a quality of life index used for health economics considerations
Measured: 132 months
Oxford Knee Score
It is a patient-reported form and consists of 12 questions on the influence of the knee (surgical side) on daily activities or pain.
Measured: 132 months
American Knee Society Score
It is used to assess knee functionality by investigator. It consists of both a clinical and a functional score
Measured: 132 months
Forgotten Joint Score
is completed by the patient and assesses his/her ability to forget about his/ her knee joint prior and after treatment
Measured: 132 months
Adverse Event Report
is completed as needed for each complication which is noted. Each complication shall be examined again at the next follow-up visit and further documented on a separate form for each visit.
Measured: 132 months
Explanted Device Form
collects information on revision surgeries for study subjects.
Measured: 132 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start20 Dec 2019
- Primary completion20 Dec 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prosthesis SurvivalStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Prospective, two arms, multicenter study that aims to involve up to 10 hospitals in Italy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giulio Maria Marcheggiani Muccioli, MD, PhD, Principal investigator, IRCCS Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244929
- Sponsor's protocol ID
- Persona-MC
- Status last verified
- May 2023
- First submitted
- 20 Jan 2020
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sabatini L, Risitano S, Parisi G, Tosto F, Indelli PF, Atzori F, Masse A. Medial Pivot in Total Knee Arthroplasty: Literature Review and Our First Experience. Clin Med Insights Arthritis Musculoskelet Disord. 2018 Jan 4;11:1179544117751431. doi: 10.1177/1179544117751431. eCollection 2018.
PubMed 29326531Van Overschelde PP, Fitch DA. Patient satisfaction at 2 months following total knee replacement using a second generation medial-pivot system: follow-up of 250 consecutive cases. Ann Transl Med. 2016 Sep;4(18):339. doi: 10.21037/atm.2016.08.41.
PubMed 27761443Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
PubMed 19844772Nam D, Nunley RM, Barrack RL. Patient dissatisfaction following total knee replacement: a growing concern? Bone Joint J. 2014 Nov;96-B(11 Supple A):96-100. doi: 10.1302/0301-620X.96B11.34152.
PubMed 25381418
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Total Knee Prosthesis Persona Medial Congruent® With Preservation or Sacrifice of the Posterior Cruciate Ligament: a Multicentric Perspective Study
- ClinicalTrials.gov ID
- NCT04244929
- Acronym / sponsor ID
- Persona-MC
- Conditions
- Prosthesis Survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 28 Jan 2020 (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.
Prospective, multicenter study on the Total Knee Prosthesis available on the market "Persona Medial Congruent® knee".
Primary endpoint
-Evaluation of the survival of the implant after 5 years of follow-up
Secondary endpoints
- Evaluation of the survival of the implant at 10 years of follow up.
- Evaluation of clinical and radiographic outcomes in Italian patients undergoing total knee replacement with the Persona Medial Congruent® implant with sacrifice or retention of the posterior cruciate ligament (PCL)
Detailed description
Prospective, multicenter study on the Total Knee Prosthesis available on the market "Persona Medial Congruent® knee" Up to 10 Italian centers will provide a maximum of 200 patients undergoing total knee replacement with Persona prosthesis and Medial Congruent® insert.
20 cases per center will be performed, 10 with posterior cruciate ligament sacrifice, 10 with posterior cruciate ligament preservation.
Patients will be recruited and enrolled in the study according to the inclusion and exclusion criteria specified below. In order to minimize the selection bias, patients will be enrolled consecutively; the first 10 patients will constitute a treatment group and the remaining 10 the complementary group.
Each patient will sign an informed consent for participation in the prospective study. The patients will be recruited at the Orthopedic and Traumatological Clinic 2nd of the Rizzoli Orthopedic Institute on an outpatient or hospitalization basis.
After the surgical treatment, the patient will continue his hospitalization at the Orthopedic and Traumatological Clinic 2nd of the Rizzoli Orthopedic Institute and, if deemed appropriate by the medical team, he will be discharged by planning the subsequent post-operative checks and diagnostic evaluations.
The data will be collected by investigators and provided to the Promoter center.
The Co-investigator who will evaluate the results will be blind to the assignment to the treatment group of the subjects in the study. The promoter of the study is the owner of the data and therefore responsible for data management. Study participants are identified with an identification code. All sensitive personal data will be stored in accordance with the current data privacy guidelines. All information will be treated with strict compliance with professional confidentiality standards. Participants will receive oral and written information relating to the processing of sensitive personal data.
The study is designed to have an alpha error of no more than 0.05. Based on an assumed 95% five-year survival, a sample size of n = 89 was calculated using SAS 9.4, Proc Power.
Assuming a 20% follow-up loss rate over five years, the study will enroll 100 patients in each patient group, then a total of 200 patients. The data collected from 200 patients (100 in each subgroup) will be archived in a descriptive way and will be the basis of all published study reports.
The categorical data (for example, gender) will be summarized using counts, percentages and the 95% confidence interval (CI), in the periods of interest. Continuous data, such as age, will be summarized using means, medians, standard deviation, minimum, maximum and 95% CI in the periods of interest. Implant survival and return to function will be summarized using the Kaplan-Meier method and presented as percentages and confidence intervals.
The expected duration of the study is 11 years, which corresponds to the time dedicated to the approval of the Ethics Committee, the enrollment of all patients, the completion of the 10-year follow-up, data analysis and preparation of the final report. The first 12 months will focus on patient enrollment. The study subjects will be involved from the moment of the intervention until the end of the 10-year follow-up (as per the current protocol 10 years FU ± 2 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, two arms, multicenter study that aims to involve up to 10 hospitals in Italy
| Arm | Type | Receives |
|---|---|---|
| PCL removal | Experimental | Procedure: Total knee arthroplasty, Device: Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament sacrificePatients will undergo surgery by sacrificing the PCL |
| PCL preservation | Active comparator | Procedure: Total knee arthroplasty, Device: Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament retainingPatients will undergo surgery with retaining the PCL |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patient qualifies for a primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
- Patient is willing and able to complete scheduled study procedures and follow-up evaluations
- Independent of study participation, patient is a candidate for commercially available Persona MC knee implants. Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
- Patient has participated in the Informed Consent process and has signed the Ethics Committee approved 'Informed Consent'.
Key exclusion criteria (12 listed)
- Patient is currently participating in any other surgical intervention studies or pain management studies
- Patient is unwilling or unable to give consent or to comply with the follow-up program.
- Patient meets exclusion criteria of the Instruction for Use Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them.
- Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint
- Insufficient bone stock on femoral or tibial surfaces
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 |
|---|---|---|
| Total knee arthroplastyTotal knee arthroplasty using standard anterior approach. | Procedure or surgery | PCL preservation, PCL removal |
| Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament retainingPatients will be implanted with this medial pivoting knee prosthesis. Posterior Cruciate Ligament will be retained | Device | PCL preservation |
| Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament sacrificePatients will be implanted with this medial pivoting knee prosthesis. Posterior Cruciate Ligament will be sacrificed | Device | PCL removal |
Primary outcome
Evaluate the safety based on implant survivorship at 5 years follow up
Time frame: 72 months
Implant survival will be evaluated by radiographic parameters on standard and long leg standing radiographs that indicate prosthesis mobilization (radiolucency lines, fracture, osteolysis)
12 secondary outcomes
Evaluate the safety based on implant survivorship at 10 years follow up
Time frame: 132 months
Evaluation of pain
Time frame: 132 months
Evaluation of medication taken by the patient
Time frame: 132 months
Evaluation of muscle strength
Time frame: 132 months
Return to work
Time frame: 132 months
Patient Satisfaction Questionnaire
Time frame: 132 months
Euro Quality of Life-5 Dimensions-5 Levels Health Questionnaire
Time frame: 132 months
Oxford Knee Score
Time frame: 132 months
American Knee Society Score
Time frame: 132 months
Forgotten Joint Score
Time frame: 132 months
Adverse Event Report
Time frame: 132 months
Explanted Device Form
Time frame: 132 months
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 31 May 2023.
- Background: PubMed 29326531Sabatini L, Risitano S, Parisi G, Tosto F, Indelli PF, Atzori F, Masse A. Medial Pivot in Total Knee Arthroplasty: Literature Review and Our First Experience. Clin Med Insights Arthritis Musculoskelet Disord. 2018 Jan 4;11:1179544117751431. doi: 10.1177/1179544117751431. eCollection 2018.
- Background: PubMed 27761443Van Overschelde PP, Fitch DA. Patient satisfaction at 2 months following total knee replacement using a second generation medial-pivot system: follow-up of 250 consecutive cases. Ann Transl Med. 2016 Sep;4(18):339. doi: 10.21037/atm.2016.08.41.
- Results publication: PubMed 19844772Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
- Results publication: PubMed 25381418Nam D, Nunley RM, Barrack RL. Patient dissatisfaction following total knee replacement: a growing concern? Bone Joint J. 2014 Nov;96-B(11 Supple A):96-100. doi: 10.1302/0301-620X.96B11.34152.
- Individual participant dataSharing planned: No
Related trials for Prosthesis Survival
Active, not recruiting
Survivorship of Attune Primary Total Knee Prosthesis
Noninflammatory Degenerative Joint Disease
RecruitingObservational study
Multicenter Mpact DM France
Total Hip Arthroplasty, Survival, Prosthesis
Active, not recruitingObservational study
Survival of Implant-Supported All-Ceramic Prostheses
Partial Edentulism, Disorder of Prostheses and Implants
Active, not recruitingObservational study
Local and Systemic Inflammatory Bone Alterations Related to Dental Implant Survival.
Peri Implant Mucositis, Peri Implant Bone Loss
Active, not recruitingObservational study
Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement
Prosthesis Survival, Prosthesis; Cardiac, Heart, Functional Disturbance as Result
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.
Giulio Maria Marcheggiani Muccioli, MD, PhD principal investigator
IRCCS Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty, Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament retaining and Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament sacrifice in people with Prosthesis Survival, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 9 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: finished, as of the sponsor's last update on 31 May 2023. 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 Italy. 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?
Evaluate the safety based on implant survivorship at 5 years follow up (time frame: 72 months). 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 NCT04244929, which also lists 4 linked publications.
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 31 May 2023.