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Clinical study to evaluate safety and efficacy of OA Kneetrac (SP1000 ™) of Changmi Medical Co. in patients with degenerative knee arthritis

Clinical study to evaluate safety and efficacy of OA Kneetrac (SP1000 ™) of Changmi Medical Co. in patients with degenerative knee arthritis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0003907
Enrollment
30
Registered
2019-05-14
Start date
2018-07-13
Completion date
Unknown
Last updated
2019-05-20

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

Conditions

None listed

Interventions

Medical Device : Interventional Medical Device Information Product name: OA Kneetrac (SP1000) Item Authorization Name: manual orthodontic appliance (1st grade) Conditions of use: about 2 hours / day W

Sponsors

Chonbuk National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adult men and women over 20 years of age 2) Diagnosis: Osteoarthritis of the Knee 3) On the anterior and posterior plane radiographs of the knee in the standing posture, patients with ? and ? grade according to Kellgren-Lawrence (K-L) 4) After hearing the detailed explanation of the human body test and fully understanding, he / she has decided to voluntarily participate and agreed in writing

Exclusion criteria

Exclusion criteria: 1) Those who have undergone lower limb surgery and cortisone injection therapy within the last 3 months (do not limit the use of drug treatments such as steroids and nonsteroidal anti-inflammation) 2) those with ligament injuries, knee joint infections, inflammatory joint disease, fibromyalgia, symptoms of neuromuscular compression in the spine, central nervous system disease, polyneuropathy, cognitive impairment 3) Any person who is deemed unsuitable for taking the examination

Design outcomes

Primary

MeasureTime frame
Western Ontario and McMaster Universities Osteoarthritis Index

Secondary

MeasureTime frame
visual analog scale

Countries

Korea, Republic of

Contacts

Public ContactSeung-Rok Kang

Chonbuk National University Hospital

srkang@mdctc.or.kr+82-63-259-3458

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026