Osteoarthritis, KneeNCT05128851
High Tibial Osteotomy With/Without Arthroscopy.
A study testing HTO, Arthroscopy treatment and Micro fractures in people with Osteoarthritis, Knee and Meniscus; Degeneration, run by Centre of Postgraduate Medical Education at 1 site in Poland.
Trial summary
This study will compare Hight Tibial Osteotomy with or without arthroscopically repair intra-articular knee lesions in patients with early stages of Osteoarthritis.The purpose of this study is evaluate if addition of arthroscopy to HTO 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, Meniscus; Degeneration
- What is being tested?
- HTO, Arthroscopy treatment and Micro fractures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 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
- Intraarticular lesions in MRI
- 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
- multilligament 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.
Poland1 site, 1 recruiting
- Recruiting
Department of Orthopaedics and Traumatology, Centre of Postgraduate Medical Education, Professor A. Gruca Teaching Hospital
Otwock, Masovian Voivodeship, 05-400
Rafal Kaminski, MD PhD, +48227794031 ext. 469, rkaminski@spskgruca.pl
Stanislaw Pomianowski, MD PhD Prof, +48227794031 ext. 481, spom@spskgruca.pl
About this study
Official title: Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes of Hight Tibial Osteotomy With or Without Concomitant Arthroscopic Treatment of Knee Intraarticular Lesions.
This study will compare Hight Tibial Osteotomy with or without arthroscopically repair intra-articular knee lesions in patients with early stages of Osteoarthritis.The purpose of this study is evaluate if addition of arthroscopy to HTO provides better clinical, radiological and laboratory outcomes.
Read the detailed description
Intraarticular knee lesions are often in patients with early stages of osteoarthritis. The most frequent findings are degenerative meniscus/meniscal tears and cartilage degeneration. Degenerative meniscal lesions or meniscal tears are often incidental findings without any complains from patients. In the current literature there is no evidence for good clinical outcomes after arthroscopically treatment degenerative meniscus. Cartilage injuries are common in osteoarthritic knee and depending on grading of chondromalacia are usually treated by microfractures. By this time the choice of performed surgery depends on surgeons personal assessment. The investigators believe that concomitant intraarticular procedures added to HTO will provide better clinical outcomes.
- Conditions
- Osteoarthritis, Knee, Meniscus; Degeneration
- Being tested
- HTO, Arthroscopy treatment, Micro fractures
- Keywords
- HTO, Degenerative Meniscus, Osteoarthritis, Microfracture
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTOProcedure or surgery
Hight Tibial Osteotomy
Arthroscopy treatmentProcedure or surgery
Arthroscopy treatment
Micro fracturesProcedure or surgery
Micro fractures
| Study group | Role | What they receive |
|---|---|---|
| High Tibial Osteotomy and arthroscopy | Active comparator | High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions. Receives: Procedure: HTO; Procedure: Arthroscopy treatment |
| High Tibial Osteotomy | Sham comparator | Descending High Tibial Osteotomy with arthroscopy without treatment of intraarticular lesions. Receives: Procedure: HTO |
| High Tibial Osteotomy, arthroscopy and microfractures | Active comparator | High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions and microfracture. Receives: Procedure: HTO; Procedure: Arthroscopy treatment; Procedure: Micro fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS
Knee Injury and Osteoarthritis Outcome Score
Measured: 12 months
KOOS
Knee Injury and Osteoarthritis Outcome Score
Measured: 24 months
IKDC
International Knee Documentation Committee - Subjective Knee Evaluation Form
Measured: 12 months
IKDC
International Knee Documentation Committee - Subjective Knee Evaluation Form
Measured: 24 months
VAS
Visual Analog Scale
Measured: 12 months
VAS
Visual Analog Scale
Measured: 24 months
Blood test
no inflammatory reaction - CRP, Il-6, CTx
Measured: 2 day
Blood test
no inflammatory reaction - CRP, Il-6, CTx
Measured: 6 weeks
Blood test
no inflammatory reaction - CRP, Il-6, CTx
Measured: 12 weeks,
Secondary outcomes (4)
Kinematic MRI with [chondrogram]
Meniscus healing, cartilage quality
Measured: 2 day,
Kinematic MRI with [chondrogram]
Meniscus healing, cartilage quality
Measured: 24 months
X-ray - Baldini projection
Patellofemoral joint measurements
Measured: 2 day
X-ray - Baldini projection
Patellofemoral joint measurements
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start15 Jul 2020
- Primary completion30 May 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafał Kamiński, Centre of Postgraduate Medical Education
- Investigators
- Rafał Kamiński, Principal investigator, PCME, Otwock, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128851
- Sponsor's protocol ID
- HTO_artro
- Status last verified
- Nov 2021
- First submitted
- 3 Jul 2020
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes of Hight Tibial Osteotomy With or Without Concomitant Arthroscopic Treatment of Knee Intraarticular Lesions.
- ClinicalTrials.gov ID
- NCT05128851
- Acronym / sponsor ID
- HTO_artro
- Conditions
- Osteoarthritis, Knee, Meniscus; Degeneration
- Keywords
- HTO, Degenerative Meniscus, Osteoarthritis, Microfracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 22 Nov 2021 (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.
This study will compare Hight Tibial Osteotomy with or without arthroscopically repair intra-articular knee lesions in patients with early stages of Osteoarthritis.The purpose of this study is evaluate if addition of arthroscopy to HTO provides better clinical, radiological and laboratory outcomes.
Detailed description
Intraarticular knee lesions are often in patients with early stages of osteoarthritis. The most frequent findings are degenerative meniscus/meniscal tears and cartilage degeneration. Degenerative meniscal lesions or meniscal tears are often incidental findings without any complains from patients. In the current literature there is no evidence for good clinical outcomes after arthroscopically treatment degenerative meniscus. Cartilage injuries are common in osteoarthritic knee and depending on grading of chondromalacia are usually treated by microfractures. By this time the choice of performed surgery depends on surgeons personal assessment. The investigators believe that concomitant intraarticular procedures added to HTO will provide better clinical outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Tibial Osteotomy and arthroscopy | Active comparator | Procedure: HTO, Procedure: Arthroscopy treatmentHigh Tibial Osteotomy with arthroscopically treatment of intraarticular lesions. |
| High Tibial Osteotomy | Sham comparator | Procedure: HTODescending High Tibial Osteotomy with arthroscopy without treatment of intraarticular lesions. |
| High Tibial Osteotomy, arthroscopy and microfractures | Active comparator | Procedure: HTO, Procedure: Arthroscopy treatment, Procedure: Micro fracturesHigh Tibial Osteotomy with arthroscopically treatment of intraarticular lesions and microfracture. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Knee medial compartment or patellofemoral osteoarthritis in medical interview and physical examination
- Intraarticular lesions in MRI
- Confirmation of cartilage degeneration/damage and knee malalignment in radiological tests
Key exclusion criteria (6 listed)
- no informed consent to participate in the study
- age under 18 years or above 65
- multilligament 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
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 |
|---|---|---|
| HTOHight Tibial Osteotomy | Procedure or surgery | High Tibial Osteotomy, High Tibial Osteotomy and arthroscopy, High Tibial Osteotomy, arthroscopy and microfractures |
| Arthroscopy treatmentArthroscopy treatment | Procedure or surgery | High Tibial Osteotomy and arthroscopy, High Tibial Osteotomy, arthroscopy and microfractures |
| Micro fracturesMicro fractures | Procedure or surgery | High Tibial Osteotomy, arthroscopy and microfractures |
Primary outcome
KOOS
Time frame: 12 months
Knee Injury and Osteoarthritis Outcome Score
KOOS
Time frame: 24 months
Knee Injury and Osteoarthritis Outcome Score
IKDC
Time frame: 12 months
International Knee Documentation Committee - Subjective Knee Evaluation Form
IKDC
Time frame: 24 months
International Knee Documentation Committee - Subjective Knee Evaluation Form
VAS
Time frame: 12 months
Visual Analog Scale
VAS
Time frame: 24 months
Visual Analog Scale
Blood test
Time frame: 2 day
no inflammatory reaction - CRP, Il-6, CTx
Blood test
Time frame: 6 weeks
no inflammatory reaction - CRP, Il-6, CTx
Blood test
Time frame: 12 weeks,
no inflammatory reaction - CRP, Il-6, CTx
4 secondary outcomes
Kinematic MRI with [chondrogram]
Time frame: 2 day,
Kinematic MRI with [chondrogram]
Time frame: 24 months
X-ray - Baldini projection
Time frame: 2 day
X-ray - Baldini projection
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
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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.
Rafał Kamiński principal investigator
PCME, Otwock, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HTO, Arthroscopy treatment and Micro fractures in people with Osteoarthritis, Knee and Meniscus; Degeneration, 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 3 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 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 (+48227794031 ext. 469, rkaminski@spskgruca.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS (time frame: 12 months). The study lists 9 primary outcomes in all. 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 22 Nov 2021.