OsteonecrosisNCT04072055
MOTO Post-marketing Surveillance Study
An observational study of Osteonecrosis and Osteo Arthritis Knee, run by Medacta International SA at 2 sites in Belgium.
Trial summary
The prospective, multicentric, observational study has the aims to monitor the performance of the MOTO medial unicompartmental knee system in the treatment of patients with knee disease requiring a UKA. 150 patients will be recruited in 18 months and will be reviewed until 5 years follow-up visit after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteonecrosis, Osteo Arthritis Knee
- What is being tested?
- MOTO Medial
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 2 sitesBelgium
- Study dates
- 25 Sep 2019to 16 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 150 patients
Who may be able to join
- Patients with unicompartmental tibiofemoral osteoarthritis (OA) of the knee that meet the indications for use of Medacta implant included in this study (on-label use);
- Patients suffering from unilateral osteoarthritis or osteonecrosis of a single knee compartment;
- Frontal deformity < 10° (evaluated on weight-bearing long-axis x-rays);
- Flexion contracture < 10°;
- Intact ligaments;
- Patients willing and able to provide written informed consent for participation in the study;
Show all 9Show fewer
- Patient's age over 18 years old;
- Patient with BMI < 40 kg/m2;
- Patients willing to comply with the pre and post-operative evaluation schedule.
Who cannot join
- Patients with one or more medical conditions identified as a contraindication in the labelling on any Medacta implants used in this study;
- Any patient who cannot or will not provide informed consent for participation in the study;
- Patients who need a revision surgery;
- Patients who had previously undergone high tibial osteotomy or anterior cruciate ligament (ACL) reconstruction;
- Patients with BMI ≥ 40 kg/m2;
- Patients unable to understand and take action;
- Any case not described in the inclusion criteria.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
AZ Zeno Campus Knokke-Heist
Knokke-Heist, 8300
Clinique Saint-Joseph
Liège, 4000
About this study
Official title: MOTO MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY: OPEN, PROSPECTIVE, MULTICENTRIC, OBSERVATIONAL STUDY
The prospective, multicentric, observational study has the aims to monitor the performance of the MOTO medial unicompartmental knee system in the treatment of patients with knee disease requiring a UKA. 150 patients will be recruited in 18 months and will be reviewed until 5 years follow-up visit after surgery. The primary objective of the study is to evaluate the prosthesis survival at 5 years.
- Conditions
- Osteonecrosis, Osteo Arthritis Knee
- Being tested
- MOTO Medial
- Keywords
- Unicompartmental Knee Arthroplasty, UKA, antomic femoral component, anatomic tibial component
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOTO MedialDevice
MOTO medial unicompartmental knee system
| Study group | Role | What they receive |
|---|---|---|
| MOTO medial | Patients suitable fulfilling the standard criteria for the implantation of unicondylar implant. Receives: Device: MOTO Medial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthesis survival
survivorship analysis according to Kaplan-Meier method at 5 years after surgery
Measured: 5 years
Secondary outcomes (3)
New Knee Society Score (KSS)
Functionality and symptom of operated knee will be evaluated by New KSS score
Measured: preoperative, 3 months, 1, 3 and 5 years
Radiological analysis
Postoperative stability and fixation of the device will be assessed by standard radiological exams
Measured: preoperative, postoperative, 3 months, 1, 3 and 5 years
Complication
Intraoperative and postoperative complication will be collected during all duration of the study
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start25 Sep 2019
- Primary completion16 Mar 2023
- Study completion16 Mar 2023
Why it stopped: recruitment difficulty in the centers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteonecrosisStudies 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
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072055
- Sponsor's protocol ID
- P02.021.01
- Status last verified
- Mar 2023
- First submitted
- 26 Aug 2019
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOTO MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY: OPEN, PROSPECTIVE, MULTICENTRIC, OBSERVATIONAL STUDY
- ClinicalTrials.gov ID
- NCT04072055
- Acronym / sponsor ID
- P02.021.01
- Conditions
- Osteonecrosis, Osteo Arthritis Knee
- Keywords
- Unicompartmental Knee Arthroplasty, UKA, antomic femoral component, anatomic tibial component
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment difficulty in the centers
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 28 Aug 2019 (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 prospective, multicentric, observational study has the aims to monitor the performance of the MOTO medial unicompartmental knee system in the treatment of patients with knee disease requiring a UKA. 150 patients will be recruited in 18 months and will be reviewed until 5 years follow-up visit after surgery. The primary objective of the study is to evaluate the prosthesis survival at 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOTO medial | – | Device: MOTO MedialPatients suitable fulfilling the standard criteria for the implantation of unicondylar implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 150 patients
Key inclusion criteria (9 listed)
- Patients with unicompartmental tibiofemoral osteoarthritis (OA) of the knee that meet the indications for use of Medacta implant included in this study (on-label use);
- Patients suffering from unilateral osteoarthritis or osteonecrosis of a single knee compartment;
- Frontal deformity < 10° (evaluated on weight-bearing long-axis x-rays);
- Flexion contracture < 10°;
- Intact ligaments;
Key exclusion criteria (7 listed)
- Patients with one or more medical conditions identified as a contraindication in the labelling on any Medacta implants used in this study;
- Any patient who cannot or will not provide informed consent for participation in the study;
- Patients who need a revision surgery;
- Patients who had previously undergone high tibial osteotomy or anterior cruciate ligament (ACL) reconstruction;
- Patients with BMI ≥ 40 kg/m2;
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 |
|---|---|---|
| MOTO MedialMOTO medial unicompartmental knee system | Device | MOTO medial |
Primary outcome
Prosthesis survival
Time frame: 5 years
survivorship analysis according to Kaplan-Meier method at 5 years after surgery
3 secondary outcomes
New Knee Society Score (KSS)
Time frame: preoperative, 3 months, 1, 3 and 5 years
Radiological analysis
Time frame: preoperative, postoperative, 3 months, 1, 3 and 5 years
Complication
Time frame: up to 5 years
Results and safety
The study was stopped early (reason given: recruitment difficulty in the centers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Osteonecrosis
Active, not recruitingObservational study
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
Knee Pain Chronic, Osteoarthritis, Knee
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Not yet recruiting
DEXA Bone Density Analysis of the CoreHip® Prosthesis System
Primary Osteoarthritis, Cartilage Degeneration
Active, not recruitingObservational study
The Medacta Quadra-P Anteverted Study
Arthrosis, Traumatic Arthritis
RecruitingObservational study
The Medacta International SMS Post-Marketing Surveillance Study
Arthrosis, Traumatic Arthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteonecrosis and Osteo Arthritis Knee, run by Medacta International SA at 2 sites in Belgium.
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 7 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: stopped early, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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 was stopped early (reason given: recruitment difficulty in the centers). Results are not available in the source record.
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?
Prosthesis survival (time frame: 5 years). 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 20 Mar 2023.