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Completed

NCT Number: NCT02622204

The Effect of Corrective Osteotomy on in Vivo Cartilage Mechanobiology in Patients With Knee Osteoarthritis

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic for Orthopaedics and Traumatology, University Hospital basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Corrective osteotomy

Procedure

corrective osteotomy for varus alignment

Other names: Corrective osteotomy (CO)

Primary outcomes

  1. change in load-induced biomarker concentration

    Time frame: 6 months

Secondary outcomes

  1. knee adduction moment

    Time frame: 6 months

    knee adduction moment during walking

  2. mechanical axis alignment

    Time frame: 6 months

  3. knee osteoarthritis outcome scale

    Time frame: 12 months

  4. synovial fluid biomarker concentration

    Time frame: 0 months

  5. level of synovial inflammation

    Time frame: 0 months

  6. level of gene expression

    Time frame: 0 months

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

The Effect of Corrective Osteotomy on in Vivo Cartilage Mechanobiology in Patients With Knee Osteoarthritis: Cross-sectional Observational Single-centre Study

Acronym: Osteotomy

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2015
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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