NCT02091830

Brief Summary

The purpose of this study is to assess whether radiographic osteoarthritis severity (OA; Kellgren-Lawrence scale) is associated with self-reported improvement in pain after non-surgical treatments (physiotherapy, pain killers, injection, other treatments). The hypothesis is that radiographic OA severity is inversely associated with self-reported improvement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,262

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

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

January 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

October 20, 2015

Status Verified

October 1, 2015

Enrollment Period

1.5 years

First QC Date

March 18, 2014

Last Update Submit

October 16, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-reported improvement

    Assessed using the question: Has your pain improved? Response categories: pain free; better; unchanged; worse

    2-5 years after consulting orthopedic surgeon

Study Arms (1)

Non-surgical treatment

Drug: Paracetamol and nonsteroidal antiinflammatory drug (NSAID)Other: PhysiotherapyDrug: Cortisone InjectionOther: Others

Interventions

Non-surgical treatment
Non-surgical treatment
OthersOTHER
Non-surgical treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

2200 patients with knee osteoarthritis not eligible for at total knee arthroplasty

You may qualify if:

  • Not eligible for at total knee arthroplasty

You may not qualify if:

  • Ipsilateral knee arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopedic Surgery

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

AcetaminophenAnti-Inflammatory Agents, Non-SteroidalPhysical Therapy ModalitiesCortisoneBro protein, Drosophila

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnalgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic AgentsTherapeuticsRehabilitationPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Michael Rathleff, MSc

    Department of Occupational Therapy and Physiotherapy, Aalborg University Hospital, Denmark.

    STUDY CHAIR
  • Mikkel M Andersen, MSc

    Department of Mathematical Sciences, Aalborg University

    STUDY CHAIR
  • Ole Simonsen, MD, DMSc

    Department of Orthopedic Surgery

    PRINCIPAL INVESTIGATOR
  • Christina A Derosche, BSc

    Department of Orthopedic Surgery

    STUDY CHAIR
  • Signe B Pedersen

    Department of Orthopedic Surgery

    STUDY CHAIR
  • Søren T Skou, MSc

    Orthopedic Surgery Research Unit + Department of Health Science and Technology, Aalborg University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DMSc

Study Record Dates

First Submitted

March 18, 2014

First Posted

March 19, 2014

Study Start

January 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 20, 2015

Record last verified: 2015-10

Locations