NCT03684850

Brief Summary

This study investigates the effects of unloader knee brace, biomechanical footwear device and exercise therapy on pain, physical function and quality of life in patients with knee osteoarthritis. The aim is to find more effective treatment strategies to delay or prevent heavy knee replacement surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

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

Study Start

First participant enrolled

December 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

January 31, 2020

Status Verified

July 1, 2019

Enrollment Period

2.8 years

First QC Date

January 30, 2017

Last Update Submit

January 30, 2020

Conditions

Osteoarthritis,Knee

Keywords

Knee bracebiomechanical footwearexerciseRCT

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Pain intensity at 4 months: VAS

    Visual Analog Scale for Pain (score of 100 mm). No pain (score of 0), worst imaginable pain (score of 100).

    4 months

Secondary Outcomes (15)

  • Change from baseline clinical symptoms at 4 months.

    4 months

  • Change from baseline Health-Related Quality of Life at 4 months: SF-36

    4 months

  • Change from baseline isometric knee extension and flexion forces at 4 months.

    4 months

  • Change from baseline walking speed gait parameter at 4 months.

    4 months

  • Change from baseline cadence gait parameter at 4 months.

    4 months

  • +10 more secondary outcomes

Study Arms (3)

Exercise therapy group

ACTIVE COMPARATOR

(n = 40)

Other: Home-based exercise

Knee brace and exercise group

EXPERIMENTAL

(n = 40)

Other: Home-based exerciseDevice: Knee brace

Footwear device group

EXPERIMENTAL

(n = 40)

Device: Biomechanical footwear device

Interventions

Home-based exerciseOTHER

Home-based exercises three times per week.

Exercise therapy groupKnee brace and exercise group
Knee braceDEVICE

Progressive use of knee brace each day during activities of daily living.

Knee brace and exercise group
Biomechanical footwear deviceDEVICE

Progressive use of footwear each day during activities of daily living.

Footwear device group

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • moderate or severe knee pain (\>40mm on a VAS scale 0-100mm)
  • radiographic knee osteoarthritis (Kellgren-Lawrence grades 1-3)
  • age between 45 and 70 years

You may not qualify if:

  • inflammatory joint disease
  • acute (\<6 months) knee trauma
  • arthroscopic surgery in the past six months
  • a planned knee replacement surgery or other planned surgical treatment of the knee
  • knee injections in the past 3 months
  • superficial wounds at the knee area
  • arterial insufficiency
  • severe varicosities
  • impaired vision
  • postural difficulties
  • body-mass index (BMI) \>35kg/m2
  • fibromyalgia
  • rheumatoid arthritis or other active rheumatoid inflammatory disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Finland Central Hospital

Jyväskylä, 40700, Finland

Location

MeSH Terms

Conditions

Osteoarthritis, KneeMotor Activity

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Jari Ylinen, Ph.D., M.D.

    Central Finland Hospital District

    PRINCIPAL INVESTIGATOR

  • Arja Häkkinen, Ph.D.

    Central Finland Hospital District

    STUDY CHAIR

  • Konsta Pamilo, M.D.

    Central Finland Hospital District

    STUDY CHAIR

  • Ari Heinonen, Ph.D.

    University of Jyväskylä, Finland

    STUDY CHAIR

  • Joost Dekker, Ph.D.

    VU University Medical Center, Amsterdam, Netherlands

    STUDY CHAIR

  • Jari Arokoski, Ph.D, M.D.

    University of Eastern Finland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2017

First Posted

September 26, 2018

Study Start

December 1, 2016

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

January 31, 2020

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)