Total Knee ArthoplastyNCT04982198
Robotic-assisted Versus Conventional Total Knee Arthroplasty
A study testing ROSA assisted TKA in people with Total Knee Arthoplasty, run by Zimmer Biomet at 1 site in China.
Trial summary
This is a multicenter, prospective and randomized controlled pre-market clinical Trial. Study subjects will be randomized into one of two operative groups: 1) TKA assisted with ROSA® Knee System; 2) TKA with conventional surgical instrumentation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Total Knee Arthoplasty
- What is being tested?
- ROSA assisted TKA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2021to 31 May 2023
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is age between 18 and 85 years old, inclusive;
- Patient qualifies for a primary TKA based on the investigator's clinical judgement;
- Patient is a candidate for commercially available Persona® Knee Joint Prosthese which is compatible with the ROSA® Knee System;
- Patient is willing and able to provide written Informed Consent.
Who cannot join
- Patient planning to receive bilateral TKA surgery within 3 months;
- Patient who has undergone revision surgery for partial or total knee arthroplasty of the ipsilateral knee；
- Bone tumor patient who has undergone bilateral TKA;
- Stable, painless ipsilateral knee arthrodesis within a satisfactory function and position;
- Patient who has received partial or total knee arthroplasty for the contralateral knee within 6 months prior to scheduled primary TKA;
- Patient has active, local infection or previous intra-articular infection in the affected joint;
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- Insufficient bone stock on femoral or tibial surfaces;
- Skeletal immaturity;
- Osteomalacia or any metabolic disorder which may impair bone formation;
- Patient has neurologic disorders (e.g. Stroke);
- Patient hs diseases that could lead to prosthesis instability, failure of prosthesis fixation or postoperative complications (e.g. Arthrodesis, Scoliosis, Lumbar Stenosis)
- Patient has a hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum);
- Patient has hip pathology severely limiting range of motion (e.g. arthrodesis, severe contractures, chronic severe dislocation);
- Patients with severe knee instability caused by incomplete collateral ligaments, cruciate ligaments, and posterolateral structural injury;
- Rheumatoid arthritis accompanied by an ulcer of the skin or history of recurrent breakdown of the skin;
- Patient has severe angular knee deformity of >20° varus or >20° valgus;
- Patient has a known or suspected sensitivity or allergy to one or more of the implant materials;
- Patient has other contraindications specified by the implant manufacturer;
- Patient is pregnant or considered a member of a protected population (e.g. prisoner, mentally incompetent);
- In the past 1 month participated in or is participating in clinical trials related to other drugs and medical devices;
- Any other conditions that the investigator considers inappropriate for participation in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robotic-assisted Versus Conventional Total Knee Arthroplasty: A Multicenter and Randomized Controlled Clinical Trial
This is a multicenter, prospective and randomized controlled pre-market clinical Trial. Study subjects will be randomized into one of two operative groups: 1) TKA assisted with ROSA® Knee System; 2) TKA with conventional surgical instrumentation.
Read the detailed description
The objective of this clinical trial is to measure the effectiveness and safety of the ROSA® Knee System in assisting surgeons with bone resections and implant positioning optimization through early clinical and radiographic outcomes compared with conventional surgical instrumentation in total knee arthroplasty (TKA).
- Conditions
- Total Knee Arthoplasty
- Being tested
- ROSA assisted TKA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROSA assisted TKAProcedure or surgery
Robotic assisted total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| TKA assisted with ROSA® Knee System | Experimental | TKA assisted with ROSA® Knee System Receives: Procedure: ROSA assisted TKA |
| TKA with conventional surgical instrumentation | Active comparator | TKA with conventional surgical instrumentation Receives: Procedure: ROSA assisted TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical axis alignment
Deviation from neutral mechanical axis alignment based on full-leg weight-bearing X-ray at 6 weeks (±2 week) postoperatively.
Measured: 6 weeks (±2 week) postoperatively
Secondary outcomes (1)
Coronal Lower Limb Alignment
Coronal Lower Limb Alignment based on full-leg weight-bearing X-ray at 6 weeks (±2 week) postoperatively.
Measured: 6 weeks (±2 week) postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start7 Jul 2021
- Primary completion30 Dec 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthoplastyStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yonggang Zhou, Principal investigator, PLA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982198
- Sponsor's protocol ID
- CEA2019-05K
- Status last verified
- Jun 2023
- First submitted
- 19 Jul 2021
- Last updated
- 26 Jun 2023
- 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 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-assisted Versus Conventional Total Knee Arthroplasty: A Multicenter and Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04982198
- Acronym / sponsor ID
- CEA2019-05K
- Conditions
- Total Knee Arthoplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 29 Jul 2021 (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.
This is a multicenter, prospective and randomized controlled pre-market clinical Trial. Study subjects will be randomized into one of two operative groups: 1) TKA assisted with ROSA® Knee System; 2) TKA with conventional surgical instrumentation.
Detailed description
The objective of this clinical trial is to measure the effectiveness and safety of the ROSA® Knee System in assisting surgeons with bone resections and implant positioning optimization through early clinical and radiographic outcomes compared with conventional surgical instrumentation in total knee arthroplasty (TKA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TKA assisted with ROSA® Knee System | Experimental | Procedure: ROSA assisted TKATKA assisted with ROSA® Knee System |
| TKA with conventional surgical instrumentation | Active comparator | Procedure: ROSA assisted TKATKA with conventional surgical instrumentation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is age between 18 and 85 years old, inclusive;
- Patient qualifies for a primary TKA based on the investigator's clinical judgement;
- Patient is a candidate for commercially available Persona® Knee Joint Prosthese which is compatible with the ROSA® Knee System;
- Patient is willing and able to provide written Informed Consent.
Key exclusion criteria (21 listed)
- Patient planning to receive bilateral TKA surgery within 3 months;
- Patient who has undergone revision surgery for partial or total knee arthroplasty of the ipsilateral knee；
- Bone tumor patient who has undergone bilateral TKA;
- Stable, painless ipsilateral knee arthrodesis within a satisfactory function and position;
- Patient who has received partial or total knee arthroplasty for the contralateral knee within 6 months prior to scheduled primary TKA;
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 |
|---|---|---|
| ROSA assisted TKARobotic assisted total knee arthroplasty | Procedure or surgery | TKA assisted with ROSA® Knee System, TKA with conventional surgical instrumentation |
Primary outcome
Mechanical axis alignment
Time frame: 6 weeks (±2 week) postoperatively
Deviation from neutral mechanical axis alignment based on full-leg weight-bearing X-ray at 6 weeks (±2 week) postoperatively.
1 secondary outcome
Coronal Lower Limb Alignment
Time frame: 6 weeks (±2 week) postoperatively
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 26 Jun 2023.
- 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.
Yonggang Zhou principal investigator
PLA Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROSA assisted TKA in people with Total Knee Arthoplasty, run by Zimmer Biomet at 1 site in China.
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 21 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 26 Jun 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 China. 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?
Mechanical axis alignment (time frame: 6 weeks (±2 week) 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 26 Jun 2023.