Knee OsteoarthritisOsteotomyNCT02622204
The Effect of Corrective Osteotomy on in Vivo Cartilage Mechanobiology in Patients With Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Our overall hypothesis is that a sudden ambulatory load reduction (caused by corrective osteotomy) leads to changes in cartilage biology that delay or reverse osteoarthritic processes determining the clinical outcome and representing an in vivo model for assessing cartilage mechanosensitivity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Corrective osteotomy
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2016to 31 Dec 2020
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with knee osteoarthritis scheduled for corrective osteotomy
Who may be able to join
- radiographically diagnosed and isolated symptomatic medial compartment knee OA undergoing corrective osteotomy (Kellgren-Lawrence grade 2 or 3)
- pain level not limiting physical activity participation
- sports participation (at least once/week).
Who cannot join
- Use of walking aids
- inability to walk for 30 minutes
- age < 18 years (before maturation) or age >70 years
- due to advanced general sarcopenia (degenerative loss of muscle mass in aging)
- body mass index (BMI) > 35 kg/m2
- active rheumatic disorder
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- prior neuromuscular impairment (e.g. stroke)
- conditions other than knee OA that could cause abnormal patterns of locomotion
- prior hip, knee, and ankle prosthesis or osteotomy of the lower extremities
- prior spine surgery; other major medical problems
- investigators and their immediate families are not permitted to be subjects
- persons who have previously completed or withdrawn from this study
- patients currently enrolled in another experimental (interventional) protocol
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic for Orthopaedics and Traumatology, University Hospital basel
Basel, Canton of Basel-City, 4031
About this study
Official title: The Effect of Corrective Osteotomy on in Vivo Cartilage Mechanobiology in Patients With Knee Osteoarthritis: Cross-sectional Observational Single-centre Study
Our overall hypothesis is that a sudden ambulatory load reduction (caused by corrective osteotomy) leads to changes in cartilage biology that delay or reverse osteoarthritic processes determining the clinical outcome and representing an in vivo model for assessing cartilage mechanosensitivity.
Read the detailed description
Although osteoarthritis (OA) is the most common degenerative joint disease and despite international research efforts, to date the factors involved in the initiation and progression of this debilitating disease are poorly understood, diagnostic markers are lacking and there is no cure. High tibial osteotomy (HTO) is a well-accepted therapy for patients with knee OA and varus alignment aimed at re-establishing a more even distribution of ambulatory load between the affected medial knee compartment and the lateral knee compartment. However, the survival rate of HTO is only around 75% after 5 years. There is some evidence that the change in ambulatory load after HTO may be more relevant than the post-operative static alignment although this relationship has not yet been investigated. Because of the large changes in ambulatory load with HTO, the investigators propose that corrective osteotomy may serve as a valuable model for studying the effect of changes in ambulatory load on in vivo cartilage mechanobiology in patients with knee osteoarthritis. Our previous work has shown that serum biomarkers for cartilage increase after a 30-minute walking exercise (termed 'walking stress test') and indicated that these changes may be associated with the accumulated ambulatory load during the test.
Patients with medial compartment knee OA and varus alignment will be clinically assessed (including mechanical axis measurement from radiographs) and complete questionnaires on physical function prior to corrective osteotomy. Patients will complete a walking stress test with blood sampling to assess load-induced changes in serum biomarker concentrations, and undergo gait analysis to assess the external knee adduction moment. Once full load bearing is achieved, the mechanical axis will be measured from radiographs. Patients will complete the questionnaires and a second walking stress test with blood sampling and undergo gait analysis 6 months after corrective osteotomy. At the 12-month follow-up, subjects will complete the questionnaires.
- Conditions
- Knee Osteoarthritis
- Being tested
- Corrective osteotomy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corrective osteotomyProcedure or surgery
Also called Corrective osteotomy (CO)
corrective osteotomy for varus alignment
| Study group | Role | What they receive |
|---|---|---|
| Corrective osteotomy | patients with knee osteoarthritis undergoing corrective osteotomy Receives: Procedure: Corrective osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in load-induced biomarker concentration
Measured: 6 months
Secondary outcomes (6)
knee adduction moment
knee adduction moment during walking
Measured: 6 months
mechanical axis alignment
Measured: 6 months
knee osteoarthritis outcome scale
Measured: 12 months
synovial fluid biomarker concentration
Measured: 0 months
level of synovial inflammation
Measured: 0 months
level of gene expression
Measured: 0 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study start1 Jan 2016
- Primary completion31 Aug 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annegret Mündermann, PhD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622204
- Sponsor's protocol ID
- EKNZ 2015-224
- Acronym
- Osteotomy
- Status last verified
- Oct 2021
- First submitted
- 2 Dec 2015
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Mundermann A, Nuesch C, Herger S, Liphardt AM, Chammartin F, De Pieri E, Egloff C. Load-induced blood marker kinetics in patients with medial knee compartment osteoarthritis are associated with accumulated load and patient reported outcome measures. F1000Res. 2024 Jan 12;12:299. doi: 10.12688/f1000research.131702.2. eCollection 2023.
PubMed 38882712De Pieri E, Nuesch C, Pagenstert G, Viehweger E, Egloff C, Mundermann A. High tibial osteotomy effectively redistributes compressive knee loads during walking. J Orthop Res. 2023 Mar;41(3):591-600. doi: 10.1002/jor.25403. Epub 2022 Jul 6.
PubMed 35730475
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Corrective Osteotomy on in Vivo Cartilage Mechanobiology in Patients With Knee Osteoarthritis: Cross-sectional Observational Single-centre Study
- ClinicalTrials.gov ID
- NCT02622204
- Acronym / sponsor ID
- Osteotomy / EKNZ 2015-224
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 4 Dec 2015 (estimated)
- 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.
Our overall hypothesis is that a sudden ambulatory load reduction (caused by corrective osteotomy) leads to changes in cartilage biology that delay or reverse osteoarthritic processes determining the clinical outcome and representing an in vivo model for assessing cartilage mechanosensitivity.
Detailed description
Although osteoarthritis (OA) is the most common degenerative joint disease and despite international research efforts, to date the factors involved in the initiation and progression of this debilitating disease are poorly understood, diagnostic markers are lacking and there is no cure. High tibial osteotomy (HTO) is a well-accepted therapy for patients with knee OA and varus alignment aimed at re-establishing a more even distribution of ambulatory load between the affected medial knee compartment and the lateral knee compartment. However, the survival rate of HTO is only around 75% after 5 years. There is some evidence that the change in ambulatory load after HTO may be more relevant than the post-operative static alignment although this relationship has not yet been investigated. Because of the large changes in ambulatory load with HTO, the investigators propose that corrective osteotomy may serve as a valuable model for studying the effect of changes in ambulatory load on in vivo cartilage mechanobiology in patients with knee osteoarthritis. Our previous work has shown that serum biomarkers for cartilage increase after a 30-minute walking exercise (termed 'walking stress test') and indicated that these changes may be associated with the accumulated ambulatory load during the test.
Patients with medial compartment knee OA and varus alignment will be clinically assessed (including mechanical axis measurement from radiographs) and complete questionnaires on physical function prior to corrective osteotomy. Patients will complete a walking stress test with blood sampling to assess load-induced changes in serum biomarker concentrations, and undergo gait analysis to assess the external knee adduction moment. Once full load bearing is achieved, the mechanical axis will be measured from radiographs. Patients will complete the questionnaires and a second walking stress test with blood sampling and undergo gait analysis 6 months after corrective osteotomy. At the 12-month follow-up, subjects will complete the questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corrective osteotomy | – | Procedure: Corrective osteotomypatients with knee osteoarthritis undergoing corrective osteotomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with knee osteoarthritis scheduled for corrective osteotomy
Key inclusion criteria (3 listed)
- radiographically diagnosed and isolated symptomatic medial compartment knee OA undergoing corrective osteotomy (Kellgren-Lawrence grade 2 or 3)
- pain level not limiting physical activity participation
- sports participation (at least once/week).
Key exclusion criteria (13 listed)
- Use of walking aids
- inability to walk for 30 minutes
- age < 18 years (before maturation) or age >70 years
- due to advanced general sarcopenia (degenerative loss of muscle mass in aging)
- body mass index (BMI) > 35 kg/m2
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 |
|---|---|---|
| Corrective osteotomyAlso: Corrective osteotomy (CO)corrective osteotomy for varus alignment | Procedure or surgery | Corrective osteotomy |
Primary outcome
change in load-induced biomarker concentration
Time frame: 6 months
6 secondary outcomes
knee adduction moment
Time frame: 6 months
mechanical axis alignment
Time frame: 6 months
knee osteoarthritis outcome scale
Time frame: 12 months
synovial fluid biomarker concentration
Time frame: 0 months
level of synovial inflammation
Time frame: 0 months
level of gene expression
Time frame: 0 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 6 Oct 2021.
- Derived from this study: PubMed 38882712Mundermann A, Nuesch C, Herger S, Liphardt AM, Chammartin F, De Pieri E, Egloff C. Load-induced blood marker kinetics in patients with medial knee compartment osteoarthritis are associated with accumulated load and patient reported outcome measures. F1000Res. 2024 Jan 12;12:299. doi: 10.12688/f1000research.131702.2. eCollection 2023.
- Derived from this study: PubMed 35730475De Pieri E, Nuesch C, Pagenstert G, Viehweger E, Egloff C, Mundermann A. High tibial osteotomy effectively redistributes compressive knee loads during walking. J Orthop Res. 2023 Mar;41(3):591-600. doi: 10.1002/jor.25403. Epub 2022 Jul 6.
- Individual participant dataSharing planned: Undecided
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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.
Annegret Mündermann, PhD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 13 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 6 Oct 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 Switzerland. 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?
change in load-induced biomarker concentration (time frame: 6 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 NCT02622204, which also lists 2 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 6 Oct 2021.