Knee Arthroplasty, TotalNCT07212296
Randomized Controlled Trial Comparing Robotic-Assisted Versus Conventional Total Knee Arthroplasty
A study testing Conventional total knee replacement and Robotic TKR in people with Knee Arthroplasty, Total and Robotic Assisted Arthroplasty, run by Hospital de Terrassa at 1 site in Spain.
Trial summary
To evaluate whether patients undergoing robotic-assisted TKA achieve better clinical-functional, radiological, and satisfaction outcomes compared with those undergoing the conventional technique, and whether operative time and complications do not increase significantly Read more about this study
- Who is it for?
- Ages 54 to 85 years
- Conditions the study is for
- Knee Arthroplasty, Total, Robotic Assisted Arthroplasty, Arthropathy of Knee
- What is being tested?
- Conventional total knee replacement and Robotic TKR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2021to 31 Oct 2024
- 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 54 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with knee arthropaty recquiring TKR
Who cannot join
- Cognitive disease
- Deformity greater than 15º of varus or 10º of valgus
- Postraumatic arthritis
- Inflamatory disease
- Other than "Persona PS" implant design
- Previus surgery
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital de Terrassa - Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227
About this study
Official title: Robotic-Assisted Versus Conventional Total Knee Arthroplasty: A Randomized Controlled Trial With 2-Year Follow-Up
To evaluate whether patients undergoing robotic-assisted TKA achieve better clinical-functional, radiological, and satisfaction outcomes compared with those undergoing the conventional technique, and whether operative time and complications do not increase significantly
Read the detailed description
To compare clinical, functional, quality-of-life, and radiological outcomes between robotic-assisted total knee arthroplasty (RA-TKA) and conventional total knee arthroplasty (C-TKA).
- Being tested
- Conventional total knee replacement, Robotic TKR
- Keywords
- Robotic, Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional total knee replacementProcedure or surgery
Knee replacement without robotic technology
Robotic TKRProcedure or surgery
Total knee replacement WITH robotic technology
| Study group | Role | What they receive |
|---|---|---|
| Conventional total knee replacement | Placebo comparator | PAtietns undergoing conventional TKR Receives: Procedure: Conventional total knee replacement |
| Robotic TKR | Experimental | PAtietns undergoing robotic TKR Receives: Procedure: Robotic TKR |
What is being measured
The primary outcome is the main question the study is designed to answer.
IKDC
standardized international system for documenting and evaluating knee problems. The IKDC Subjective Knee Form is a patient-reported outcome measure that was developed to assess both surgical and non-surgical outcomes across a wide range of knee conditions and treatment approaches.
Measured: 2 years follow up after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Jun 2021
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Alonso, Hospital de Terrassa
- Investigators
- Javier Alonso-Rodriguez Piedra, Orthopaedic Surgeon, MdPhD, Principal investigator, Hospital de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212296
- Sponsor's protocol ID
- 01-21-105-058
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 8 Oct 2025
- 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 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-Assisted Versus Conventional Total Knee Arthroplasty: A Randomized Controlled Trial With 2-Year Follow-Up
- ClinicalTrials.gov ID
- NCT07212296
- Acronym / sponsor ID
- 01-21-105-058
- Keywords
- Robotic, Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Hospital de TerrassaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 8 Oct 2025 (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.
To evaluate whether patients undergoing robotic-assisted TKA achieve better clinical-functional, radiological, and satisfaction outcomes compared with those undergoing the conventional technique, and whether operative time and complications do not increase significantly
Detailed description
To compare clinical, functional, quality-of-life, and radiological outcomes between robotic-assisted total knee arthroplasty (RA-TKA) and conventional total knee arthroplasty (C-TKA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional total knee replacement | Placebo comparator | Procedure: Conventional total knee replacementPAtietns undergoing conventional TKR |
| Robotic TKR | Experimental | Procedure: Robotic TKRPAtietns undergoing robotic TKR |
Who may qualify
- Ages
- 54 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with knee arthropaty recquiring TKR
Key exclusion criteria (6 listed)
- Cognitive disease
- Deformity greater than 15º of varus or 10º of valgus
- Postraumatic arthritis
- Inflamatory disease
- Other than "Persona PS" implant design
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 |
|---|---|---|
| Conventional total knee replacementKnee replacement without robotic technology | Procedure or surgery | Conventional total knee replacement |
| Robotic TKRTotal knee replacement WITH robotic technology | Procedure or surgery | Robotic TKR |
Primary outcome
IKDC
Time frame: 2 years follow up after surgery
standardized international system for documenting and evaluating knee problems. The IKDC Subjective Knee Form is a patient-reported outcome measure that was developed to assess both surgical and non-surgical outcomes across a wide range of knee conditions and treatment approaches.
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 8 Oct 2025.
- 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.
Javier Alonso-Rodriguez Piedra, Orthopaedic Surgeon, MdPhD principal investigator
Hospital de Terrassa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional total knee replacement and Robotic TKR in people with Knee Arthroplasty, Total and Robotic Assisted Arthroplasty, run by Hospital de Terrassa 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: finished, as of the sponsor's last update on 8 Oct 2025. 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. Some participants in this study may receive a placebo. 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?
IKDC (time frame: 2 years follow up 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 8 Oct 2025; AzTrials last refreshed its copy on 31 Oct 2026.