The multicenter randomized controlled trial on the effectiveness of the medial side single hinge knee brace with strap (Unloader One) and the double hinge knee brace with center bridge (CB brace) for varus knee osteoarthritis

The multicenter randomized controlled trial on the effectiveness of the medial side single hinge knee brace with strap (Unloader One) and the double hinge knee brace with center bridge (CB brace) for varus knee osteoarthritis - The multicenter randomized controlled trial on the effectiveness of the medial side single hinge knee brace (Unloader One) and the double hinge knee brace (CB brace) for varus knee osteoarthritis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012368

Enrollment

150

Registered

2013-11-21

Start date

2013-11-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varus knee osteoarthritis

Interventions

Control(Only the use of analgesics and intra-articular injection) The medial side single hinge knee brace with strap(Unloader One) The double hinge knee brace with center bridge(CB brace)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Varus knee osteoarthritis on the basis of the criteria of American College of Rheumatology (Altman et al. Arthritis Rheum. 29:1039-49.1986) The radiographic severity according to the Kellgren-Lawrence system of Grade 2 or higher

Exclusion criteria

Exclusion criteria: Present use of a brace An operation on the knee within the previous six months History of arthroplasty in the knee Arthritis other than osteoarthritis Skin disease Severe leg edema Peripheral vascular disease Varicose veins Severe dementia

Design outcomes

Primary

Measure	Time frame
Visual Analogue Scale(VAS)(Rest/Walking) MOS Short-Form 36-Item Health Survey (SF-36) Western Ontario and McMaster Universities Arthritis Index (WOMAC)	—

Secondary

Measure	Time frame
5m comfortable and maximum walking speed Time Up and Go test Isometric knee extension strength Analgesic usage in the past month The number of intra-articular injections in the past month	—

Countries

Japan

Contacts

Public ContactKiyomi Yoshimoto

Nara Medical University Department of General Medicine

kym@naramed-u.ac.jp0744-22-3051(3471)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026