NCT02622204

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2015

Completed
28 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

October 6, 2021

Status Verified

October 1, 2021

Enrollment Period

4.7 years

First QC Date

December 2, 2015

Last Update Submit

October 5, 2021

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • change in load-induced biomarker concentration

    6 months

Secondary Outcomes (6)

  • knee adduction moment

    6 months

  • mechanical axis alignment

    6 months

  • knee osteoarthritis outcome scale

    12 months

  • synovial fluid biomarker concentration

    0 months

  • level of synovial inflammation

    0 months

  • +1 more secondary outcomes

Study Arms (1)

Corrective osteotomy

patients with knee osteoarthritis undergoing corrective osteotomy

Procedure: Corrective osteotomy

Interventions

Corrective osteotomyPROCEDURE

corrective osteotomy for varus alignment

Also known as: Corrective osteotomy (CO)
Corrective osteotomy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with knee osteoarthritis scheduled for corrective osteotomy

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Orthopaedics and Traumatology, University Hospital basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 38882712DERIVED

  • De 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.

    PMID: 35730475DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, synovium biopsies

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Annegret Mündermann, PhD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 4, 2015

Study Start

January 1, 2016

Primary Completion

August 31, 2020

Study Completion

December 31, 2020

Last Updated

October 6, 2021

Record last verified: 2021-10

Locations

CH(1)