- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00124462
Trial of Realignment Therapy for Treatment of Medial Knee Osteoarthritis
A Randomized Trial of Realignment Therapy for Treatment of Medial Knee Osteoarthritis
The overall objective of this 3-year project is to determine whether the provision of realignment therapy in patients with medial knee osteoarthritis (OA) relieves knee pain and improves function. The researchers will test the hypothesis that compared to control treatment, the use of realignment therapy (valgus knee brace + motion control shoes + orthosis) is effective in medial knee OA.
The specific aims are:
- To undertake a 30 week randomized crossover clinical trial in patients with medial knee osteoarthritis to determine whether provision of realignment therapy leads to lower pain scores and improved function during the time of this treatment than during the use of a placebo treatment;
- To perform an open label follow-up study to track use and effectiveness of treatment. This project will be co-funded by DonJoy Orthopedic, a knee bracing company.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- Boston University, School of Medicine
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Trial participants must meet American College of Rheumatology (ACR) criteria for osteoarthritis with knee pain, aching or stiffness on most of the past 30 days and evidence on radiograph of a definite osteophyte. In addition, because the researchers are interested in recruiting persons with medial knee osteoarthritis, participants will need to have evidence of disease in this compartment on their radiographs, and not have lateral compartment or patellofemoral compartment disease. Medial disease is based on definitions used in the researcher's previous publications as definite radiographic OA + at least grade 1 medial narrowing (0-3 scale) using an atlas from the Osteoarthritis Research Society International.
Exclusion Criteria:
- Individuals with clinical evidence of patellofemoral disease or knee pathology (other than medial compartment OA) likely to be causing their knee pain.
- Individuals who usually use an ambulation aid to walk such as a cane, crutch, walker or wheel chair.
- Amputation of foot or previous major trauma to foot that would raise concerns about whether an insert might worsen foot pain. Persons with foot lesions such as sores or ulcers in which redistributing load in the foot might be dangerous, will be excluded.
- Known neuropathy from diabetes or for other reasons.
- Past history of deep venous thrombosis.
- Pain emanating more from back or hip than from knee as determined by screening questionnaire
- Low pain score on WOMAC, a widely used and well validated questionnaire to assess knee symptoms. To evaluate response, the researchers will require that patients have a minimal score of at least 4 out of 10 on at least 2 of 5 questions, or a total of greater than 15 out of 50 for the WOMAC pain scale in the eligible knee at pre-randomization phone call and visit, and at randomization visit. This will allow us to detect response to treatment if response occurs.
- Planning to move from area within 9 months of study screening
- Symptomatic comorbid disease limits walking more than knee pain (per screening questionnaire)
- Receiving corticosteroid injections in the month prior to starting the trial. No other treatments will trigger exclusion, although for patients who have been on glucosamine +/or chondroitin +/or nonsteroidal anti-inflammatory drug (NSAID) the researchers will require that they must have taken these treatments for at least 2 months prior to onset of trial and to commit to not start a new treatment throughout the trial.
- Bilateral total knee replacements (TKR) or plan for TKR in next 6 months for affected knee.
- Known other causes of arthritis including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), gout, psoriatic arthritis, pseudogout.
- Failure to pass 4 week run-in test.
- Volunteers in a pre-contemplative state (persons who would not consider realignment therapy as a therapeutic option for their knee OA).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: Realignment to Placebo
Realigning knee brace and custom orthodic- A valgus brace, customized functional orthotic for neutral foot position and motion control footwear.
|
A valgus brace, customized functional orthotic for neutral foot position and motion control footwear
A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole
|
Andet: Placebo to Realignment
Non realigning knee brace and flat orthodic- A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole
|
A valgus brace, customized functional orthotic for neutral foot position and motion control footwear
A neutral brace that does not have any varus/valgus angulation, control foot orthodic and shoes with flexible midsole
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mean Change WOMAC Pain Scale (Most Symptomatic Treated Knee)
Tidsramme: Baseline and 12 weeks
|
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.
|
Baseline and 12 weeks
|
Change in WOMAC Function Scale (Most Symptomatic Treated Knee)
Tidsramme: Baseline and 12 weeks
|
The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a self-administered health status measure for pain, stiffness, and function in patients with knee or hip OA.
It measures Pain (5 questions), Stiffness (2 questions), and Function (17 questions).
The WOMAC function score ranges from 0-68, all items are scored on a scale of 0-4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely) for difficulty of specific functions.
Lower overall function scores indicate higher levels of functioning or less difficulty performing a list of 17 specific activities.
|
Baseline and 12 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: David J Hunter, Boston University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-24147
- H133G040201 (Andet bevillings-/finansieringsnummer: NIDRR)
Plan for individuelle deltagerdata (IPD)
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