NCT00414557

Brief Summary

To investigate the effects of quadriceps strengthening on the adductor moment in individuals with medial knee OA and whether quadriceps strengthening has a different effect on the adductor moment in individuals with and without knee malalignment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for phase_2 knee-osteoarthritis

Timeline
Completed

Started May 2004

Typical duration for phase_2 knee-osteoarthritis

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2006

Completed
Last Updated

December 22, 2006

Status Verified

December 1, 2006

First QC Date

December 20, 2006

Last Update Submit

December 21, 2006

Conditions

Keywords

Musculoskeletal diseasesJoint diseases

Outcome Measures

Primary Outcomes (2)

  • Adduction moment

  • Time points: 0 and 13 weeks

Secondary Outcomes (7)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire

  • Numerical rating scales for pain

  • Quadriceps and hamstrings strength

  • Self-selected walking speed

  • Dynamic balance using step test

  • +2 more secondary outcomes

Interventions

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pain in the knee
  • Osteophytes on knee x-ray
  • Self-reported pain on the inner aspect of the study knee
  • Osteophytes in the medial compartment of the knee joint and
  • Medial joint space narrowing greater than lateral joint space narrowing on x-ray

You may not qualify if:

  • Knee surgery within the previous 6 months
  • History of lower limb joint replacements
  • Systemic arthritic conditions such as rheumatic or psoriatic arthritis
  • Valgus knee deformity (\> 5º)
  • Inability to walk without the use of walking aids
  • Intending to start a lower limb strengthening program in the next 3 months
  • Seeking or currently receiving physiotherapy for OA knee

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Melbourne

Melbourne, Victoria, 3040, Australia

Location

Related Publications (1)

  • Lim BW, Hinman RS, Wrigley TV, Sharma L, Bennell KL. Does knee malalignment mediate the effects of quadriceps strengthening on knee adduction moment, pain, and function in medial knee osteoarthritis? A randomized controlled trial. Arthritis Rheum. 2008 Jul 15;59(7):943-51. doi: 10.1002/art.23823.

MeSH Terms

Conditions

Osteoarthritis, KneeMusculoskeletal DiseasesJoint Diseases

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisRheumatic Diseases

Study Officials

  • Kim Bennell, PhD

    University of Melbourne

    PRINCIPAL INVESTIGATOR
  • Rana Hinman, PhD

    University of Melbourne

    PRINCIPAL INVESTIGATOR
  • Tim Wrigley, MSc

    University of Melbourne

    PRINCIPAL INVESTIGATOR
  • Boon W Lim, MSc

    University of Melbourne

    PRINCIPAL INVESTIGATOR
  • Leena Sharma, MD

    Northwestern University Medical School, Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2006

First Posted

December 21, 2006

Study Start

May 1, 2004

Study Completion

December 1, 2006

Last Updated

December 22, 2006

Record last verified: 2006-12

Locations