SHARK Hinman 2016
The University of MelbourneDataset description
Demographic, baseline and 6-month follow-up data from the SHARK trial. 164 patients aged over 50 years with symptomatic radiographic medial knee osteoarthritis. Intervention was walking shoes with triple-density, variable-stiffness midsoles and mild lateral-wedge insoles worn daily (intervention, n = 83) versus conventional walking shoes (comparator, n = 81). All data presented in the results paper (Annals of internal medicine. 2016;165(6):381-389) available in XLSX format.Identifiers
Source Study
Trial name (public)
Modified SHoes for osteoARthritis of the Knee: the SHARK studyTrial acronym
SHARK
Trial ID
ACTRN12613000851763
Purpose
Treatment
Phase
Not Applicable
Funding
Government body,National Health and Medical Research Council
Scientific enquiries
A/Prof Rana Hinman
Brief Summary
Knee osteoarthritis (OA) affects many older people and is a major public health problem. Afflicted individuals suffer from knee pain and physical dysfunction that impacts dramatically on quality of life. Osteoarthritis has no cure and often gets worse over time. Non-toxic treatments that reduce symptoms and assist patient self-management over the long-term are needed. Increased joint loading (force across the knee) is central to pain development and increased risk of disease progression in peopl .... Read more
Key Inclusion Criteria
Aged>50; Knee pain on most days of the last month; Kellgren & Lawrence Grade 2 or above radiographic changes Presence of medial osteoarthritis on x-ray (grade 1 medial osteophytes AND grade 1 medial joint space narrowing, as defined by a standard radiographic atlas); Minimum average knee pain score of 4 on an 11-point numerical rating scale
Key Exclusion Criteria
Predominant lateral tibiofemoral osteoarthritis on x-ray (lateral osteophytes (joint space narrowing) greater than medial); Intra-articular corticosteroid injection or knee surgery to either knee within past 3 months; Systemic arthritic conditions; History of knee joint replacement or high tibial osteotomy or plan for surgery to either knee in next 6 months; Other muscular, joint or neurological condition affecting lower limb function; Current or previous 6 months use of shoe insert, knee or ank .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 164
Min. age 50 Years
Max. age 0 No limit
Sex Both males and females
Condition category Knee Osteoarthritis
Condition code Musculoskeletal
Intervention
Intervention code Rehabilitation , Treatment: Devices
Intervention: modified walking shoes (that are denser/more rigid on the outside (laterally) compared to the inside (medially)) designed to unload the knee joint of people with knee osteoarthritis- Gel Melbourne OA shoes (Asics). Participants will be instructed to wear their allocated shoes every day for six months, for at least 4 hours per day. Shoe wear will be monitored by use of log-books and pedometers.
Comparison
Control group Active
Control condition: non-modified walking shoes- Gel Odyssey shoes (Asics). Participants will be instructed to wear their allocated shoes every day for six months, for at least 4 hours per day. Shoe wear will be monitored by use of log-books and pedometers.
Outcomes
Outcome: Pain assessed by 11-point numeric rating scaleTimepoint: Baseline and 6 months
Outcome: Self-reported physical function assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) physical function sub-scaleTimepoint: Baseline and 6 months
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
All data in the published results paper will be made available (Ann Intern Med. 2016;165:381-389. doi:10.7326/M16-0453).
When will data be available?
12/06/2016 - 12/06/2031 (a period of 15 years from publication)
Available to whom?
Data will be made available to researchers as required for specific, approved analyses. Data will be provided from locked, cleaned, and de- identified study database. Requests will be reviewed by the Principal Investigator prior to approval.
Available for what types of analyses?
The investigators endorse the concept of data sharing to advance medical science. All requests for data sharing will be reviewed by the Principal Investigator to ensure no conflict with any planned sub analyses and to ensure that the data are shared in an ethical and protected manner. Analyses aimed to improve treatment of knee osteoarthritis for non-commercial purposes are eligible.