Knee Prosthetic SurgeryNCT05365022
Clinical and Radiological Results in Robotic Assisted Knee Prosthetic Surgery With ROSA® Knee System
A study testing ROSA® System Robotic Assisted Knee Prosthetic Surgery in people with Knee Prosthetic Surgery and Robotic Assistance, run by Borja Alcobía-Díaz MD, PhD at 1 site in Spain.
Trial summary
Comparing clinical and radiological results of patients after prosthetic surgery conventionally with no robotic assistance and ROSA® Knee prosthetic surgery robotic assistance. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Prosthetic Surgery, Robotic Assistance
- What is being tested?
- ROSA® System Robotic Assisted Knee Prosthetic Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2021to Sep 2022
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee osteoarthritis requiring PS Knee Prosthesis
Who cannot join
- Not meeting Inclusion Criteria
- Requiring Constrained Prosthesis
- Metal Allergy
- Neurological disorders.
- Cognitive impairment
- Not giving consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
Borja Alcobia-Díaz, MD, PhD, 913303001 ext. 3638, dralcobiacot@gmail.com
About this study
Official title: Clinical and Radiological Results in Robotic Assisted Knee Prosthetic Surgery With ROSA® Knee System.
Comparing clinical and radiological results of patients after prosthetic surgery conventionally with no robotic assistance and ROSA® Knee prosthetic surgery robotic assistance.
- Conditions
- Knee Prosthetic Surgery, Robotic Assistance
- Being tested
- ROSA® System Robotic Assisted Knee Prosthetic Surgery
- Keywords
- Knee prosthetic surgery robotic assistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROSA® System Robotic Assisted Knee Prosthetic SurgeryDevice
Robotic Assisted Knee Prosthetic Surgery using ROSA® (Zimmer-Biomet) System
| Study group | Role | What they receive |
|---|---|---|
| Conventional Non-Robotic Assisted Knee Prosthetic Surgery | No intervention | Not described |
| ROSA® System Robotic Assisted Knee Prosthetic Surgery | Active comparator | Not described Receives: Device: ROSA® System Robotic Assisted Knee Prosthetic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility of ROSA® (Zimmer-Biomet) Robotic assisting system for knee prosthetic surgery
Correct lower limb mechanical alignment
Measured: 6 months after surgery
Secondary outcomes (9)
Mobility
Range of Motion in degrees
Measured: 1 year after surgery
Technique reproducibility between surgeons
Reproducing mechanical alignment in degrees
Measured: Intraoperative
Patient satisfaction
Patient satisfaction in a numeric scale from 1 to 10
Measured: 1 year after surgery
Time to Recovery
Time to feel patients themselves better than presurgery in months
Measured: 1 year after surgery
Time to home discharge
Hospital stay in days between surgery and discharging home
Measured: 1 month
Pain Control
Pain measurement with Visual Analogue Scale (VAS)
Measured: 1 year after surgery
Technique Timing at Operating Room (OR)
Timing in minutes to measure reproducibility between surgeons
Measured: Intraoperative
Implant Stability
Presence of varus / valgus instability
Measured: 1 year after surgery
Complications
Major /Minor Complications
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start10 Feb 2021
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Prosthetic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Borja Alcobía-Díaz MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Borja Alcobía-Díaz MD, PhD, Hospital San Carlos, Madrid
- Investigators
- Borja Alcobia-Díaz, MD, PhD, Study chair, Clinical Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365022
- Sponsor's protocol ID
- 22/081-EC_P
- Status last verified
- May 2022
- First submitted
- 25 Feb 2022
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Email contact
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Results in Robotic Assisted Knee Prosthetic Surgery With ROSA® Knee System.
- ClinicalTrials.gov ID
- NCT05365022
- Acronym / sponsor ID
- 22/081-EC_P
- Conditions
- Knee Prosthetic Surgery, Robotic Assistance
- Keywords
- Knee prosthetic surgery robotic assistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Borja Alcobía-Díaz MD, PhDUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 6 May 2022 (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.
Comparing clinical and radiological results of patients after prosthetic surgery conventionally with no robotic assistance and ROSA® Knee prosthetic surgery robotic assistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Non-Robotic Assisted Knee Prosthetic Surgery | No intervention | – |
| ROSA® System Robotic Assisted Knee Prosthetic Surgery | Active comparator | Device: ROSA® System Robotic Assisted Knee Prosthetic Surgery |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Knee osteoarthritis requiring PS Knee Prosthesis
Key exclusion criteria (6 listed)
- Not meeting Inclusion Criteria
- Requiring Constrained Prosthesis
- Metal Allergy
- Neurological disorders.
- Cognitive impairment
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® System Robotic Assisted Knee Prosthetic SurgeryRobotic Assisted Knee Prosthetic Surgery using ROSA® (Zimmer-Biomet) System | Device | ROSA® System Robotic Assisted Knee Prosthetic Surgery |
Primary outcome
Utility of ROSA® (Zimmer-Biomet) Robotic assisting system for knee prosthetic surgery
Time frame: 6 months after surgery
Correct lower limb mechanical alignment
9 secondary outcomes
Mobility
Time frame: 1 year after surgery
Technique reproducibility between surgeons
Time frame: Intraoperative
Patient satisfaction
Time frame: 1 year after surgery
Time to Recovery
Time frame: 1 year after surgery
Time to home discharge
Time frame: 1 month
Pain Control
Time frame: 1 year after surgery
Technique Timing at Operating Room (OR)
Time frame: Intraoperative
Implant Stability
Time frame: 1 year after surgery
Complications
Time frame: 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Individual participant dataSharing planned: No. Email contact
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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.
Borja Alcobia-Díaz, MD, PhD study chair
Clinical Assistant
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® System Robotic Assisted Knee Prosthetic Surgery in people with Knee Prosthetic Surgery and Robotic Assistance, run by Borja Alcobía-Díaz MD, PhD at 1 site in Spain.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 May 2022. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Borja Alcobia-Díaz, MD, PhD (913303001 ext. 3638, dralcobiacot@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utility of ROSA® (Zimmer-Biomet) Robotic assisting system for knee prosthetic surgery (time frame: 6 months after surgery). 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 6 May 2022.