NCT00381563

Brief Summary

Osteoarthritis, sometimes called degenerative joint disease, is the most common form of arthritis. It occurs when the cartilage in joints wears down over time. Symptoms can include pain, tenderness, stiffness, and inflammation. Studies have suggested that symptoms of knee osteoarthritis may be caused by abnormalities at the patellofemoral joint, which is the joint between the kneecap, called the patella, and the thigh bone, called the femur. This study will determine whether wearing a knee brace that realigns the patella over the femur is effective in relieving pain and improving function in adults with knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

2 active sites

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

September 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
7.6 years until next milestone

Results Posted

Study results publicly available

June 29, 2017

Completed
Last Updated

June 29, 2017

Status Verified

May 1, 2017

Enrollment Period

2.5 years

First QC Date

September 27, 2006

Results QC Date

October 13, 2011

Last Update Submit

May 30, 2017

Conditions

Knee Osteoarthritis

Keywords

BracingPatellofemoralOsteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Change in Pain on the VIsual Analog Scale (VAS)

    The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases. It is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (best) to the right (worst).The visual analog scale (VAS) pain ranges from 0-100

    6 weeks

  • Change in WOMAC Pain Scale

    The WOMAC (Western Ontario and McMaster Osteoarthritis Index) is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions). The WOMAC pain scale ranges from 0-20. All the items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely). Lower scores indicate lower levels of pain.

    6 weeks

Secondary Outcomes (1)

  • Change in WOMAC Function Scale

    6 weeks

Study Arms (2)

Intervention to placebo

OTHER

Participants will wear the patellofemoral realigning knee brace for 6 weeks, followed by the non-aligning knee brace for 6 weeks.

Device: Patellofemoral realigning knee braceDevice: Non-aligning knee brace

Placebo to intervetion

OTHER

Participants will wear the non-aligning knee brace for 6 weeks, followed by the patellofemoral realigning knee brace for 6 weeks.

Device: Patellofemoral realigning knee braceDevice: Non-aligning knee brace

Interventions

Patellofemoral realigning knee braceDEVICE

Knee brace that changes the tracking of the patella over the femur bone

Intervention to placeboPlacebo to intervetion
Non-aligning knee braceDEVICE

Knee brace that does not change the tracking of the patella over the femur bone

Intervention to placeboPlacebo to intervetion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Knee pain on most days
  • Either isolated patellofemoral osteoarthritis or mixed patellofemoral and tibiofemoral osteoarthritis, as based on x-ray

You may not qualify if:

  • Bed- or chair-bound, usually uses an ambulation aid to walk (e.g., cane, crutch, or walker), or uses a wheelchair
  • Pain emanating more from the back or hip than from the knee, as determined by screening questionnaire
  • Low pain score on the visual analog scale (VAS) (less than 4 out of 10)
  • Plans to move from the area within 10 months of study screening
  • Symptomatic comorbid disease that limits activities more than knee pain does, as determined by screening questionnaire (e.g., congestive heart failure, chronic obstructive pulmonary disease)
  • Bilateral total knee replacements or plans for a total knee replacement of the affected knee in the next 6 months
  • Morbidly obese (body mass index greater than 35), as brace fitting and prevention of slippage of the brace will be difficult
  • Known other causes of arthritis, including rheumatoid arthritis, systemic lupus erythematosus, gout, psoriatic arthritis, and pseudogout
  • Skin breakdown at the site where the brace will be applied
  • Failure to pass the run-in test, or the brace falls down the leg during the run-in

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Boston University, School of Medicine

Boston, Massachusetts, 02118, United States

Location

New England Baptist Hospital

Boston, Massachusetts, 02120, United States

Location

Related Publications (1)

  • Hunter DJ, Harvey W, Gross KD, Felson D, McCree P, Li L, Hirko K, Zhang B, Bennell K. A randomized trial of patellofemoral bracing for treatment of patellofemoral osteoarthritis. Osteoarthritis Cartilage. 2011 Jul;19(7):792-800. doi: 10.1016/j.joca.2010.12.010. Epub 2011 Jan 11.

    PMID: 21232620RESULT

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Limitations and Caveats

There was no control group without a brace for comparison to the intervention because of concerns about unblinding.

Results Point of Contact

Title
Director of Clinical Trials
Organization
New England Baptist Hospital
pmccree@caregroup.harvard.edu
(617)754-6602

Study Officials

  • David Hunter, MD

    Boston University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2006

First Posted

September 28, 2006

Study Start

December 1, 2006

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

June 29, 2017

Results First Posted

June 29, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)