NCT04967339

Brief Summary

In patients with early to mid-stage knee osteoarthritis (OA), a conservative treatment is indicated. In medial knee OA (when mainly the medial compartment of the knee is affected by OA), lateral wedge insoles have been promoted as cost effective and simple solution. However, clinical trials report conflicting results, with some reporting no benefit while others reported a small decrease in knee pain. Recent studies reported medial OA patients to have a tendency to a plano-valgus foot deformity, which is associated with a varus lower limb alignment and an internal rotation of the tibia. Some authors thus proposed the correction of plano-valgus deformity with foot deformity correcting insoles instead of lateral wedge insoles. Until today, only one study investigated the effect of foot deformity correcting insoles (e.g. with medial arch support) as alternative to lateral wedge insoles and reported encouraging results. However, they used lateral wedge insoles with custom arch support instead of foot deformity correcting customized insoles along (without lateral wedge). Furthermore, they did not perform any biomechanical analyses. The primary object of this study is to compare the effect of foot deformity correcting insoles for plano-valgus foot deformities and lateral wedge insoles on knee load distribution, knee pain and patient reported outcome measures in early to mid-stage medial knee OA patients after 6 and 12 months.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

July 13, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

July 13, 2021

Last Update Submit

February 8, 2023

Conditions

Osteoarthritis, Knee

Keywords

Mediale Knee OsteoarthritisConservative TreatmentInsoles

Outcome Measures

Primary Outcomes (33)

  • Numeric pain scale (NRS)

    pre-treatment

  • Numeric pain scale (NRS)

    3 months

  • Numeric pain scale (NRS)

    6 months

  • Numeric pain scale (NRS)

    12 months

  • External knee adduction moment (EKAM)

    pre-treatment

  • External knee adduction moment (EKAM)

    3 months

  • External knee adduction moment (EKAM)

    6 months

  • External knee adduction moment (EKAM)

    12 months

  • Knee adduction angular impulse (KAAI)

    pre-treatment

  • Knee adduction angular impulse (KAAI)

    3 months

  • Knee adduction angular impulse (KAAI)

    6 months

  • Knee adduction angular impulse (KAAI)

    12 months

  • Western Ontario and McMaster OA Index (WOMAC)

    pre-treatment

  • Western Ontario and McMaster OA Index (WOMAC)

    3 months

  • Western Ontario and McMaster OA Index (WOMAC)

    6 months

  • Western Ontario and McMaster OA Index (WOMAC)

    9 months

  • Western Ontario and McMaster OA Index (WOMAC)

    12 months

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

    pre-treatment

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

    3 months

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

    6 months

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

    12 months

  • Oxford-12 Knee Score (OKS)

    pre-treatment

  • Oxford-12 Knee Score (OKS)

    3 months

  • Oxford-12 Knee Score (OKS)

    6 months

  • Oxford-12 Knee Score (OKS)

    12 months

  • Knee Society Score (KSS)

    pre-treatment

  • Knee Society Score (KSS)

    3 months

  • Knee Society Score (KSS)

    6 months

  • Knee Society Score (KSS)

    12 months

  • EQ-5D

    pre-treatment

  • EQ-5D

    3 months

  • EQ-5D

    6 months

  • EQ-5D

    12 months

Study Arms (2)

Foot deformity correcting insole arm

EXPERIMENTAL

Patients allocated to the "foot deformity correcting insole" arm will receive insoles to correct their foot deformities (plano-valgus foot deformity).

Device: Foot deformity correcting insoles

Lateral wedge insole arm

ACTIVE COMPARATOR

Patient allocated to the "Lateral wedge insole" arm will receive conventional lateral wedge insole.

Device: Lateral wedge insoles

Interventions

Foot deformity correcting insolesDEVICE

Foot deformity correcting insoles (e.g. insoles with medial arch support for plano-valgus deformity)

Foot deformity correcting insole arm
Lateral wedge insolesDEVICE

Lateral wedge insoles

Lateral wedge insole arm

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed Consent signed by the subject
  • Aged between 40 to 80 years
  • Early to mid-stage (KL 1 - 3) OA of the medial compartment of the knee based on X-ray and MRI images
  • Plano-valgus foot deformity based on clinical assessment
  • Ability to walk without walking aid for more than 15min

You may not qualify if:

  • Contraindications and limitations of the MD as described in the instructions for use.
  • Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject,
  • Enrolment of the PI, his/her family members, employees and other dependent persons
  • Relevant OA (Kellgren-Lawrence-Score \>2) of the lateral compartment of the knee based on X-ray and MRI images
  • BMI higher than 40 kg/m
  • Fix varus deformities over 20 degrees
  • Neurological or rheumatoid diseases of any kind
  • History of high tibial osteotomy, other realignment surgery of the knee or foot
  • Foot or ankle problems that contraindicated the use of footwear load-modifying interventions
  • Relevant ligamentous instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinik für Orthopädische Chirurgie und Traumatologie Inselspital

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Frank Klenke, Prof

    Universitätsklinik für Orthopädische Chirurgie und Traumatologie Inselspital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank Klenke, Prof

CONTACT

0041 31 632 21 11ortho@insel.ch

Andreas Hecker, MD

CONTACT

0041 31 632 21 11ortho@insel.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2021

First Posted

July 19, 2021

Study Start

December 1, 2021

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)