Osteoarthritis, KneeNCT03865524
Effect Of The Use Of Navigation In The Alignment Obtained When Performing A Total Knee Arthroplasty In Obese Patients
A study testing Total knee arthroplasty implanted with GPS navigation system and Total knee arthroplasty implanted with standard guides. in people with Osteoarthritis, Knee and Obesity, run by Pedro-José Torrijos-Garrido at 2 sites in Spain.
Trial summary
NAOBE is a randomized, open and prospective clinical trial that evaluates the accuracy to achieve an adequate mechanical axis of the lower extremity in obese patients after total knee replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Obesity, Arthropathy of Knee
- What is being tested?
- Total knee arthroplasty implanted with GPS navigation system and Total knee arthroplasty implanted with standard guides.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 2 sitesSpain
- Study dates
- 7 Feb 2019to 6 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 18 years old.
- Written informed consent according to ICH / GCP and Spanish legislation, obtained before any study procedure.
- Patient with a BMI equal to or greater than 30 Kg / m2
- Patients with clinical and radiological criteria of knee osteoarthritis.
- Patients with indication for primary TKA according to medical criteria.
Who cannot join
- Pregnancy or lactation.
- Inability to give informed consent in the absence of a legal representative.
- Subjects that are participating in a study with medicines or other medical devices.
- Those who show inability to follow the instructions or collaborate during the development of the study.
- If in the opinion of the researcher there are findings in the physical examination, abnormalities in the results of the clinical analyzes or other medical, social or psychosocial factors that could have a negative influence
- Having had a previous surgical procedure on or around the knee in the last 12 months (such as proximal tibial osteotomy, femoral osteotomy, open reduction and internal fixation for a fracture, patellectomy or patellar realignment).
Show all 9Show fewer
- Need a simultaneous bilateral TKA.
- Have a varus angle or valgus ≥ 15 °.
- Total revision knee arthroplasty.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Santa Cristina
Madrid, Madrid, 28009
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
About this study
NAOBE is a randomized, open and prospective clinical trial that evaluates the accuracy to achieve an adequate mechanical axis of the lower extremity in obese patients after total knee replacement.
Read the detailed description
Randomized, open and prospective clinical trial.
Following the surgical indication for a total knee replacement as treatment for symptomatic osteoarthritis and the confirmation of obesity (BMI equal or greater than 30 Kg/m2 ), patients will be randomly assigned (ratio 1:1) to one of the following treatments:
Control group: Total knee arthroplasty implanted with standard guides . Experimental group: Total knee arthroplasty(TKA) implanted with GPS navigation system Patient (or their legal guardian) must provide/sign the informed consent prior to inclusion in the study.
After the surgery, patients will be followed-up at 6 weeks, 3, 6 and 12 months. At those times, data regarding physical and radiological examinations, pain and functionality and health status questionnaires will be collected.
- Conditions
- Osteoarthritis, Knee, Obesity, Arthropathy of Knee
- Being tested
- Total knee arthroplasty implanted with GPS navigation system, Total knee arthroplasty implanted with standard guides.
- Keywords
- Osteoarthritis, Knee, Obesity, Knee replacement, Arthroplasty
- Medical subject headings
- Osteoarthritis, Knee, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplasty implanted with GPS navigation systemDevice
Obese patients undergoing Total Knee Arthroplasty, GPS achieved alignment
Total knee arthroplasty implanted with standard guides.Device
Obese patients undergoing Total Knee Arthroplasty, alignment achieved by using standard guides
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Total knee arthroplasty implanted with GPS navigation system. Receives: Device: Total knee arthroplasty implanted with GPS navigation system |
| Control | Active comparator | Total knee arthroplasty implanted with standard guides. Receives: Device: Total knee arthroplasty implanted with standard guides. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deviation in a mechanical axis of knees
Proportion of knees after surgery with a mechanical axis with a deviation greater than 3º
Measured: 12 months
Secondary outcomes (7)
Radiological axes (femoral)
Position angle of the femoral component: angle formed between the anatomical axis of the femur and the articular surface of the femoral component of the TKA (α).
Measured: 12 months
Radiological axes (tibial)
Position angle of the tibial component: angle formed between the anatomical axis of the tibia and the proximal surface of the tibial component of the TKA (β).
Measured: 12 months
Surgical procedure time
Surgical time
Measured: Week 1
Admission (hospital) duration
Number of days of the hospital admission
Measured: Week 1
Number of Surgical complications (Intraoperative)
Intraoperative complications
Measured: Week 1
Number of Surgical complications (perioperative)
perioperative complications
Measured: 1 to 6 weeks
Number of Surgical complications (post-operative)
postoperative complications
Measured: 1-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start7 Feb 2019
- Primary completion6 Nov 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Model description
- Randomized, Multicenter, prospective trial with a CE-marked medical device
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pedro-José Torrijos-Garrido
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pedro-José Torrijos-Garrido, Puerta de Hierro University Hospital
- Investigators
- Pedro José Torrijos Garrido, MD, PhD, Principal investigator, Hospital Universitario Puerta de Hierro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865524
- Sponsor's protocol ID
- NAOBE
- Status last verified
- Sep 2026
- First submitted
- 5 Mar 2019
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zurron Lobato M, Bartolome Garcia S, Aragones Maza P, Valverde Villar A, Ramirez Feito C, Gonzalez Gonzalez MS, Payares Herrera MC, Fernandez de Pedro SP, Jimenez Martin J, Torrijos Garrido PJ. The Use of Navigation During Total Knee Replacement Improves Precision in Achieving Mechanical Alignment in Obese Patients: A Short-Term Multicenter Randomized Clinical Trial. JB JS Open Access. 2025 Oct 22;10(4):e25.00220. doi: 10.2106/JBJS.OA.25.00220. eCollection 2025 Oct-Dec.
PubMed 41112698
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of The Use Of Navigation In The Alignment Obtained When Performing A Total Knee Arthroplasty In Obese Patients
- ClinicalTrials.gov ID
- NCT03865524
- Acronym / sponsor ID
- NAOBE
- Conditions
- Osteoarthritis, Knee, Obesity, Arthropathy of Knee
- Keywords
- Osteoarthritis, Knee, Obesity, Knee replacement, Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Pedro-José Torrijos-GarridoUniversity, hospital or other
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 7 Mar 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.
NAOBE is a randomized, open and prospective clinical trial that evaluates the accuracy to achieve an adequate mechanical axis of the lower extremity in obese patients after total knee replacement.
Detailed description
Randomized, open and prospective clinical trial.
Following the surgical indication for a total knee replacement as treatment for symptomatic osteoarthritis and the confirmation of obesity (BMI equal or greater than 30 Kg/m2 ), patients will be randomly assigned (ratio 1:1) to one of the following treatments:
Control group: Total knee arthroplasty implanted with standard guides . Experimental group: Total knee arthroplasty(TKA) implanted with GPS navigation system Patient (or their legal guardian) must provide/sign the informed consent prior to inclusion in the study.
After the surgery, patients will be followed-up at 6 weeks, 3, 6 and 12 months. At those times, data regarding physical and radiological examinations, pain and functionality and health status questionnaires will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Multicenter, prospective trial with a CE-marked medical device
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Total knee arthroplasty implanted with GPS navigation systemTotal knee arthroplasty implanted with GPS navigation system. |
| Control | Active comparator | Device: Total knee arthroplasty implanted with standard guides.Total knee arthroplasty implanted with standard guides. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women over 18 years old.
- Written informed consent according to ICH / GCP and Spanish legislation, obtained before any study procedure.
- Patient with a BMI equal to or greater than 30 Kg / m2
- Patients with clinical and radiological criteria of knee osteoarthritis.
- Patients with indication for primary TKA according to medical criteria.
Key exclusion criteria (9 listed)
- Pregnancy or lactation.
- Inability to give informed consent in the absence of a legal representative.
- Subjects that are participating in a study with medicines or other medical devices.
- Those who show inability to follow the instructions or collaborate during the development of the study.
- If in the opinion of the researcher there are findings in the physical examination, abnormalities in the results of the clinical analyzes or other medical, social or psychosocial factors that could have a negative influence
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 arthroplasty implanted with GPS navigation systemObese patients undergoing Total Knee Arthroplasty, GPS achieved alignment | Device | Experimental |
| Total knee arthroplasty implanted with standard guides.Obese patients undergoing Total Knee Arthroplasty, alignment achieved by using standard guides | Device | Control |
Primary outcome
Deviation in a mechanical axis of knees
Time frame: 12 months
Proportion of knees after surgery with a mechanical axis with a deviation greater than 3º
7 secondary outcomes
Radiological axes (femoral)
Time frame: 12 months
Radiological axes (tibial)
Time frame: 12 months
Surgical procedure time
Time frame: Week 1
Admission (hospital) duration
Time frame: Week 1
Number of Surgical complications (Intraoperative)
Time frame: Week 1
Number of Surgical complications (perioperative)
Time frame: 1 to 6 weeks
Number of Surgical complications (post-operative)
Time frame: 1-12 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 25 Sep 2026.
- Results publication: PubMed 41112698Zurron Lobato M, Bartolome Garcia S, Aragones Maza P, Valverde Villar A, Ramirez Feito C, Gonzalez Gonzalez MS, Payares Herrera MC, Fernandez de Pedro SP, Jimenez Martin J, Torrijos Garrido PJ. The Use of Navigation During Total Knee Replacement Improves Precision in Achieving Mechanical Alignment in Obese Patients: A Short-Term Multicenter Randomized Clinical Trial. JB JS Open Access. 2025 Oct 22;10(4):e25.00220. doi: 10.2106/JBJS.OA.25.00220. eCollection 2025 Oct-Dec.
- 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.
Pedro José Torrijos Garrido, MD, PhD principal investigator
Hospital Universitario Puerta de Hierro
2 sites 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 implanted with GPS navigation system and Total knee arthroplasty implanted with standard guides. in people with Osteoarthritis, Knee and Obesity, run by Pedro-José Torrijos-Garrido at 2 sites 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 5 inclusion and 9 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 25 Sep 2026. 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 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?
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?
Deviation in a mechanical axis of knees (time frame: 12 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 NCT03865524, which also lists 1 linked publication.
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 25 Sep 2026.