Data

SHARK Hinman 2016

The University of Melbourne

Dataset 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.
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Related Datasets

Source Study

Trial 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 ....
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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 ....
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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 scale
Timepoint: Baseline and 6 months

Outcome: Self-reported physical function assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) physical function sub-scale
Timepoint: Baseline and 6 months

Study Protocol: Not Available
Data Dictionary: Data dictionary

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.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au