AzTrials
AzTrials

Arthritis (Knee)AMBE_ORNCT07212777

Precision of Pacient-specific Instrumented Open Wedge High Tibial Osteotomy vs Conventional Technicque

A study testing Medial Open Wedge Hight Tibial Osteotomy using patient-specific instrumentation and Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques in people with Arthritis (Knee) and Varus Knee, run by University of Malaga at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a randomized clinical trial that will compare two surgical techniques for patients with knee osteoarthritis and varus deformity who are candidates for medial opening wedge high tibial osteotomy. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Arthritis (Knee), Varus Knee
What is being tested?
Medial Open Wedge Hight Tibial Osteotomy using patient-specific instrumentation and Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSpain
Study dates
15 Nov 2025to Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent: able to sign informed consent
  • Clinical: predominantly medial pain/limitation refractory ≥3-6 months
  • Mobility: flexion ≥90º and flexion contracture ≤10º Stability: varus/valgus and pivot-shift ≤ grade 1.
  • Radiology:
  • Medial gonarthrosis Ahlbäck I-III with preserved lateral compartment.
  • Patellofemoral Iwano 0-2 without disabling patellofemoral pain.
Show all 9Show fewer
  • Varus alignment: HKA 4-10°.
  • Predominantly tibial deformity (decreased MPTA; LDFA close to normal) according to planning.
  • Anatomy/technical feasibility: proximal tibial morphology suitable for medial opening osteotomy and PSI guide placement.

Who cannot join

  • Comorbidity/clinical situations:
  • Inflammatory arthritis (e.g., RA, spondyloarthropathies), unresolved previous joint infection or osteomyelitis.
  • Severe peripheral vasculopathy (ABI <0.7), advanced peripheral neuropathy or Charcot foot.
  • Poorly controlled diabetes (HbA1c >8.5%), advanced renal/hepatic failure (eGFR <30 ml/min/1.73 m²; Child-Pugh B/C).
  • Smoking >20 cigarettes/day without commitment to cessation; active IV drug use or uncontrolled alcoholism.
  • BMI >35 kg/m².
Show all 20Show fewer
  • Disorder affecting gait (e.g., neurological disease).
  • Inability to walk at a speed of at least 0.8m/s
  • Anatomy/radiology
  • Multiplanar deformities not correctable with isolated medial opening tibial valgus osteotomy (e.g., dominant femoral deformity).
  • Severe medial subchondral bone defect or extensive necrosis.
  • Sequelae of proximal tibia fracture or previous ipsilateral HTO that prevent correction or guide use.
  • Treatments/medication and logistics
  • Anticoagulation/antiplatelet therapy that cannot be suspended or bridged.
  • Systemic corticosteroids >10 mg/day or high-risk immunosuppressants without possibility of adjustment.
  • Intra-articular infiltration (HA/CS/PRP) within the previous 60 days (respect defined wash-out).
  • Pregnancy.
  • Participation in another interfering trial.
  • Inability to undergo CT (e.g., uncontrollable claustrophobia).
  • Inability to complete ≥12 months of follow-up.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Amparo Zamora-Mogollo contact

+34673662020

amparo.zamora@uma.es

Juan Miguel Gómez Palomo, PhD contact

jmgomezpalomo@gmail.com

Spain1 site, 1 recruiting

  • Hospital Universitario Virgen de la Victoria de Málaga

    Málaga, Málaga, 29010

    Juan Miguel Gómez-Palomo, Dr, PhD, +34647000340, jmgomezpalomo@gmail.com

    Amparo Zamora-Mogollo, MSc, +34673662020, amparo.zamora@uma.es

    Recruiting

Other trials in Spain

About this study

Official title: Precisión de la osteotomía Tibial Proximal Con Instrumental Paciente-específico vs técnica Convencional

This study is a randomized clinical trial that will compare two surgical techniques for patients with knee osteoarthritis and varus deformity who are candidates for medial opening wedge high tibial osteotomy. The goal is to evaluate whether using patient-specific 3D-printed surgical guides improves the accuracy of the bone cut compared with the conventional technique performed with anatomical landmarks and fluoroscopy.

A total of 50 adult patients will be randomly assigned to one of two groups: conventional osteotomy or osteotomy assisted by patient-specific instrumentation (PSI). The main outcome is the accuracy of the osteotomy cut, measured by comparing preoperative planning with the postoperative CT scan. Secondary outcomes include leg alignment, surgical time, radiation exposure, complications, and functional recovery assessed with validated questionnaires (KOOS, WOMAC, IKDC, EQ-5D) and gait analysis using depth cameras.

Patients will be followed for up to 12 months after surgery to evaluate clinical and radiological outcomes.

Read the detailed description

Medial opening wedge high tibial osteotomy is a well-established surgical procedure to correct knee alignment in patients with medial knee osteoarthritis and varus deformity. The accuracy of the bone cut is critical for surgical success. However, conventional techniques performed with anatomical landmarks and fluoroscopy may result in variability and suboptimal correction.

Recent advances in 3D imaging and printing allow the creation of patient-specific surgical guides designed from preoperative CT scans. These guides may improve the accuracy and reproducibility of the osteotomy.

This single-center randomized clinical trial will include 50 adult patients, randomly assigned to undergo conventional osteotomy or osteotomy assisted by patient-specific instrumentation. The main outcome is the accuracy of the osteotomy cut compared with preoperative planning. Secondary outcomes include leg alignment, surgical efficiency, radiation exposure, complications, and functional recovery. Patients will be followed for 12 months.

Being tested
Medial Open Wedge Hight Tibial Osteotomy using patient-specific instrumentation, Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques
Keywords
patient-specific instrumentation, knee osteotomy, Prospective, Randomised Controlled Trial
Medical subject headings
Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medial Open Wedge Hight Tibial Osteotomy using patient-specific instrumentationProcedure or surgery

    Medial Open Wedge Hight Tibial Osteotomy using 3D printed patient-specific instrumentation as a guide for the osteotomy

  • Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniquesProcedure or surgery

    Conventional Medial Open Wedge Hight Tibial Osteotomy

Study groups in NCT07212777
Study groupRoleWhat they receive
Conventional surgeryActive comparatorOsteotomy using conventional technique
Receives: Procedure: Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques
Patient-specific instrumentationExperimentalOsteotomy using 3D-printed patient-specific instrumentation
Receives: Procedure: Medial Open Wedge Hight Tibial Osteotomy using patient-specific instrumentation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Angular precision in AP and lateral planes

    Difference between planned and executed angles in AP and lateral planes

    Measured: Immediate postoperative period

  2. Distance to joint line

    Difference between planned and executed distance between osteotomy cut and and joint line

    Measured: Immediate postoperative period

Secondary outcomes (22)

  1. Postoperative alignment (HKA angle)

    Difference between planned and achieved hip-knee-ankle angle

    Measured: Immediate postoperative period

  2. Posterior tibial slope (PTS)

    Difference between planned and achieved tibial slope

    Measured: Immediate postoperative period

  3. Surgical time

    Duration from skin incision to closure

    Measured: Day of surgery

  4. Number of fluoroscopic images

    Total intraoperative fluoroscopy shots

    Measured: Day of surgery

  5. Radiation dose

    Cumulative radiation exposure during surgery (mGy)

    Measured: Day of surgery

  6. Intraoperative complications

    Events such as hinge fracture or neurovascular injury

    Measured: Day of surgery

  7. Postoperative complications

    Infection, delayed bone healing, thrombotic events

    Measured: From surgery to end of 12 month follow-up

  8. Reoperation

    Need for additional surgical intervention

    Measured: From surgery to end of 12 month follow-up

  9. Functional recovery

    Time to full weight-bearing without assistance

    Measured: From surgery to end of 12 month follow-up

  10. Radiographic consolidation

    Time to radiographic evidence of bone healing

    Measured: From surgery until the end of the 12 month follow-up

  11. 5 Sit to Stand Test

    Time it takes the patient to perform 5 sit to stands

    Measured: From surgery until the end of the 12 month follow-up

  12. Visual Analog Scale (VAS for pain)

    Range 0-10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse outcome.

    Measured: From surgery until the end of the 12 month follow-up

  13. Percentage of patients with a +-2º correction within the planned osteotomy

    Precision of the alignment of the knee with respect tot he planned osteotomy

    Measured: Immediate postoperative period

  14. Timed-Up-and-Go

    Time that it takes the patient to stand up from a chair and walk 10 meters, turn 180º and return to the starting position

    Measured: From surgery until the end of the 12 month follow-up

  15. Balance Test (from the Short Physical Performance Battery, SPPB)

    The balance component of the Short Physical Performance Battery (SPPB) assesses the ability to maintain three standing positions: feet together, semi-tandem, and tandem stand, each for up to 10 seconds. The test is scored from 0 to 4, where 0 = unable to hold any position, and 4 = able to hold the tandem position for 10 seconds. Higher scores indicate better balance performance.

    Measured: From surgery to end of 12 month follow-up

  16. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Each subscale scored from 0-100, where 0 = extreme problems and 100 = no problems. Higher scores indicate better outcome.

    Measured: From surgery to end of 12 month follow-up

  17. International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form

    Score range 0-100, where 0 = worst knee function and 100 = no limitations. Higher scores indicate better outcome.

    Measured: From surgery to end of 12 month follow-up

  18. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Scored 0-96, where higher scores indicate worse pain, stiffness, and physical function.

    Measured: From surgery to end of 12 month follow-up

  19. EuroQol 5 Dimensions Questionnaire (EQ-5D-5L)

    Index score range usually from -0.59 (worst health state) to 1 (perfect health); higher scores indicate better quality of life.

    Measured: From surgery to end of 12 month follow-up

  20. Lower Limb Functional Index (LLFI)

    Patient-reported questionnaire that measures lower limb functional status. It consists of 25 items scored as "yes" (1 point), "sometimes" (0.5 points), or "no" (0 points). The raw score is summed and converted to a percentage (0-100). Higher scores indicate greater disability, while lower scores indicate better functional status. Ranges from 0-100. Higher scores mean a worse outcome.

    Measured: From surgery to end of 12 month follow-up

  21. Foot Health Status Questionnaire (FHSQ)

    Patient-reported questionnaire assessing foot health across several domains: pain, function, footwear, and general foot health. Each domain score is transformed to a 0-100 scale. Higher scores indicate better foot health and function. Range: 0-100 for each domain. Higher scores mean a better outcome.

    Measured: From surgery to end of 12 month follow-up

  22. Foot Function Index (FFI)

    Patient-reported measure assessing foot pain, disability, and activity limitation. Contains 23 items scored on a visual analog scale (0-10). The total score is normalized to a 0-100 scale. Higher scores indicate greater pain, disability, and activity limitation. Range: 0-100. Higher scores mean a worse outcome.

    Measured: From surgery to end of 12 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2025
  2. Study start15 Nov 2025
  3. Primary completionSep 2027 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07212777
Sponsor's protocol ID
2025999010604889
Acronym
AMBE_OR
Status last verified
Apr 2026
First submitted
23 Sep 2025
Last updated
22 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.

    PubMed 21205966

  • Jacquet C, Sharma A, Fabre M, Ehlinger M, Argenson JN, Parratte S, Ollivier M. Patient-specific high-tibial osteotomy's 'cutting-guides' decrease operating time and the number of fluoroscopic images taken after a Brief Learning Curve. Knee Surg Sports Traumatol Arthrosc. 2020 Sep;28(9):2854-2862. doi: 10.1007/s00167-019-05637-6. Epub 2019 Jul 27.

    PubMed 31352498

  • Pang R, Jiang Z, Xu C, Shi W, Zhang X, Wan X, Bahat D, Li H, Senatov F, Bulygina I, Wang H, Zhang H, Li Z. Is Patient-Specific Instrumentation Accurate and Necessary for Open-Wedge High Tibial Osteotomy? A Meta-Analysis. Orthop Surg. 2023 Feb;15(2):413-422. doi: 10.1111/os.13483. Epub 2022 Dec 30.

    PubMed 36585795

  • Zhu X, Qian Y, Liu A, Xu P, Guo JJ. Comparative outcomes of patient-specific instrumentation, the conventional method and navigation assistance in open-wedge high tibial osteotomy: A prospective comparative study with a two-year follow up. Knee. 2022 Dec;39:18-28. doi: 10.1016/j.knee.2022.08.013. Epub 2022 Sep 14.

    PubMed 36115179

  • Cerciello S, Ollivier M, Corona K, Kaocoglu B, Seil R. CAS and PSI increase coronal alignment accuracy and reduce outliers when compared to traditional technique of medial open wedge high tibial osteotomy: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2022 Feb;30(2):555-566. doi: 10.1007/s00167-020-06253-5. Epub 2020 Sep 10.

    PubMed 32910222

  • Carey EG, Kamath AF, Vidal AF, Frush T, Alaia M, Baldwin RB, Ranawat A. Assessing the Impact of Patient-Specific Instrumentation and Fixation on Accuracy and Radiation Exposure in a Cadaveric Model of Medial Opening-Wedge High Tibial Osteotomy. Orthop J Sports Med. 2025 Jan 28;13(1):23259671241285430. doi: 10.1177/23259671241285430. eCollection 2025 Jan.

    PubMed 39881858

  • Miao Z, Li S, Luo D, Lu Q, Liu P. The validity and accuracy of 3D-printed patient-specific instruments for high tibial osteotomy: a cadaveric study. J Orthop Surg Res. 2022 Jan 29;17(1):62. doi: 10.1186/s13018-022-02956-2.

    PubMed 35093132

  • Chaouche S, Jacquet C, Fabre-Aubrespy M, Sharma A, Argenson JN, Parratte S, Ollivier M. Patient-specific cutting guides for open-wedge high tibial osteotomy: safety and accuracy analysis of a hundred patients continuous cohort. Int Orthop. 2019 Dec;43(12):2757-2765. doi: 10.1007/s00264-019-04372-4. Epub 2019 Jul 5.

    PubMed 31273430

  • Donnez M, Ollivier M, Munier M, Berton P, Podgorski JP, Chabrand P, Parratte S. Are three-dimensional patient-specific cutting guides for open wedge high tibial osteotomy accurate? An in vitro study. J Orthop Surg Res. 2018 Jul 9;13(1):171. doi: 10.1186/s13018-018-0872-4.

    PubMed 29986731

  • Jones GG, Jaere M, Clarke S, Cobb J. 3D printing and high tibial osteotomy. EFORT Open Rev. 2018 May 21;3(5):254-259. doi: 10.1302/2058-5241.3.170075. eCollection 2018 May.

    PubMed 29951264

  • Stimolo D, Leggieri F, Matassi F, Barra A, Civinini R, Innocenti M. Learning curves for high tibial osteotomy using patient-specific instrumentation: a case control study. Innov Surg Sci. 2024 Jul 3;9(3):123-131. doi: 10.1515/iss-2024-0007. eCollection 2024 Sep.

    PubMed 39309194

Questions about this trial

What is this clinical trial studying?

A study testing Medial Open Wedge Hight Tibial Osteotomy using patient-specific instrumentation and Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques in people with Arthritis (Knee) and Varus Knee, run by University of Malaga 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 9 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amparo Zamora-Mogollo (+34673662020, amparo.zamora@uma.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Angular precision in AP and lateral planes (time frame: Immediate postoperative period). The study lists 2 primary outcomes in all. 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 NCT07212777, which also lists 11 linked publications.

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 22 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in