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Osteoarthritis, KneeNCT05128864

High Tibial Osteotomy With/Without Fulkerson Osteotomy in Knee OA

A study testing High Tibial Osteotomy in people with Osteoarthritis, Knee and Patellofemoral Disorder, run by Centre of Postgraduate Medical Education at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will compare Hight Tibial Osteotomy with or without Fulkerson Osteotomy performed on patients with early stages of Osteoarthritis with patellofemoral joint disorders. The purpose of this study is evaluate which type of osteotomy provides better clinical, radiological and laboratory outcomes. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Osteoarthritis, Knee, Patellofemoral Disorder
What is being tested?
High Tibial Osteotomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
1 sitePoland
Study dates
15 Jul 2020to 30 May 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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Knee medial compartment or patellofemoral osteoarthritis in medical interview and physical examination
  • Confirmation of cartilage degeneration/damage and knee malalignment in radiological tests

Who cannot join

  • no informed consent to participate in the study
  • age under 18 years or above 65
  • multi ligament injury or single plane knee instability
  • another musculoskeletal disorders in lower limb
  • lower limb deformity requiring axis correction below 4o or above 12.5o
  • joints inflammatory diseases
  • ASA score > II

Trial locations and contacts

1 site in 1 country.

Rafał Kamiński, MD PhD contact

+48227794031 ext. 469

kaminski@spskgruca.pl

Poland1 site, 1 recruiting

  • Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital

    Otwock, Masovian Voivodeship, 05-400

    Rafal Kaminski, MD PhD, +48227794031 ext. 431, rkaminski@spskgruca.pl

    Stanislaw Pomianowski, MD PhD Prof, +48227794031 ext. 481, spom@spskgruca.pl

    Recruiting

Other trials in Poland

About this study

Official title: Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes of Hight Tibial Osteotomy With or Without Concomitant Fulkerson Osteotomy

This study will compare Hight Tibial Osteotomy with or without Fulkerson Osteotomy performed on patients with early stages of Osteoarthritis with patellofemoral joint disorders. The purpose of this study is evaluate which type of osteotomy provides better clinical, radiological and laboratory outcomes.

Read the detailed description

Progression of knee cartilage degenerative changes leads to necessary total knee arthroplasty in future, which is the most popular procedure for treating OA. HTO applied at early stages of osteoarthritis allow slow down cartilage degeneration process, but the choice of performed surgery depends on surgeons personal assessment. Patellofemoral Pain Syndrome often occurs with knee arthritis. Antero-medialisation of tibial tubercle is frequent procedures for patella maltracking. So far, both, HTO and Fulkerson osteotomy was performed separately, even if patient have symptoms from patellofemoral joint and OA. The investigators believe that simultaneously surgery of HTO and fulkerson Osteotomy provides better outcomes and significantly slow down knee degeneration.

Being tested
High Tibial Osteotomy
Keywords
HTO, Fulkerson, Osteoarthritis
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

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

  • High Tibial OsteotomyProcedure or surgery

    Surgery procedure - High Tibial Osteotomy

Study groups in NCT05128864
Study groupRoleWhat they receive
HTO and FulkersonActive comparatorHigh Tibial Osteotomy with Antero-medialisation of Tibial Tubercle
Receives: Procedure: High Tibial Osteotomy
HTOSham comparatorDescending Hight Tibial Osteotomy
Receives: Procedure: High Tibial Osteotomy

What is being measured

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

  1. Biomechanics MRI

    Patellofemoral Joints Biomechanics improvement measured

    Measured: 1 year

  2. Biomechanics MRI

    Patellofemoral Joints Biomechanics improvement measured

    Measured: 2 years

  3. Biomechanics X-ray

    Patellofemoral Joints Biomechanics improvement measured

    Measured: 12 weeks

  4. Biomechanics X-ray

    Patellofemoral Joints Biomechanics improvement measured

    Measured: 6 months

  5. Biomechanics X-ray

    Patellofemoral Joints Biomechanics improvement measured

    Measured: 12 months

  6. Biomechanics X-ray

    Patellofemoral Joints Biomechanics improvement measured

    Measured: 24 months

Secondary outcomes (22)

  1. KOOS

    Knee Injury and Osteoarthritis Outcome Score

    Measured: 12 weeks

  2. KOOS

    Knee Injury and Osteoarthritis Outcome Score

    Measured: 6 months

  3. KOOS

    Knee Injury and Osteoarthritis Outcome Score

    Measured: 12 months

  4. KOOS

    Knee Injury and Osteoarthritis Outcome Score

    Measured: 24 months

  5. IKDC

    International Knee Documentation Committee

    Measured: 12 weeks

  6. IKDC

    International Knee Documentation Committee

    Measured: 6 months

  7. IKDC

    International Knee Documentation Committee

    Measured: 12 months,

  8. IKDC

    International Knee Documentation Committee

    Measured: 24 months

  9. Tegner Lysholm

    Tegner Lysholm Knee Scoring Scale

    Measured: 12 weeks,

  10. Tegner Lysholm

    Tegner Lysholm Knee Scoring Scale

    Measured: 6 months

  11. Tegner Lysholm

    Tegner Lysholm Knee Scoring Scale

    Measured: 12 months

  12. Tegner Lysholm

    Tegner Lysholm Knee Scoring Scale

    Measured: 24 months

  13. SF-36

    The Short Form (36) Health Survey

    Measured: 12 weeks

  14. SF-36

    The Short Form (36) Health Survey

    Measured: 6 months

  15. SF-36

    The Short Form (36) Health Survey

    Measured: 12 months

  16. SF-36

    The Short Form (36) Health Survey

    Measured: 24 months

  17. VAS

    Pain Visual Analog Scale

    Measured: 12 week

  18. VAS

    Pain Visual Analog Scale

    Measured: 6 months

  19. VAS

    Pain Visual Analog Scale

    Measured: 12 months

  20. VAS

    Pain Visual Analog Scale

    Measured: 24 months

  21. Blood test

    CRP, IL-6, CTx

    Measured: 2nd day

  22. Blood test

    CRP, IL-6, CTx

    Measured: 6 weeks

Timeline

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

  1. First posted22 Nov 2021
  2. Study start15 Jul 2020
  3. Primary completion30 May 2022 (estimated)
  4. Study completion30 May 2022 (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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05128864
Sponsor's protocol ID
HTO_fulkerson
Status last verified
Nov 2021
First submitted
18 Jul 2020
Last updated
22 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing High Tibial Osteotomy in people with Osteoarthritis, Knee and Patellofemoral Disorder, run by Centre of Postgraduate Medical Education at 1 site in Poland.

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 2 inclusion and 7 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 22 Nov 2021. 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 Poland. 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?

Results are not available in the source record.

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

Contact Rafał Kamiński, MD PhD (+48227794031 ext. 469, kaminski@spskgruca.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biomechanics MRI (time frame: 1 year). The study lists 6 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 NCT05128864.

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 Nov 2021.

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