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A multicenter, prospective, randomized controlled clinical trialto compare the safety and efficacy of the single condyle knee prosthesis and the single condyle knee joint system in the treatment of single compartment osteoarthritis and other relevant diseases

A multicenter, prospective, randomized controlled clinical trialto compare the safety and efficacy of the single condyle knee prosthesis and the single condyle knee joint system in the treatment of single compartment osteoarthritis and other relevant diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17013666
Enrollment
Unknown
Registered
2017-12-04
Start date
2018-01-01
Completion date
Unknown
Last updated
2017-12-11

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

Conditions

Single compartment osteoarthritis

Interventions

Control group:Single condylar knee joint prosthesis made by other companies
experimental group :Single condylar knee joint prosthesis

Sponsors

The Drum Tower Hospital Affiliated to the medical school of Nanjing University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) non inflammatory medial arthritis of the knee joint and idiopathic osteonecrosis; 2) the cruciate ligament of the knee joint was complete; 3) the motion of the knee was more than 110 degrees, and the flexion contracture was less than 15 degrees; 4) varus knee is smaller than 15 DEG, and varus deformity can be corrected technique; 5) serious medical diseases and neuromuscular lesions that have no effect on the recovery of joint function; 6) the subjects were able to understand the purpose of the clinical trial, read the relevant information carefully, voluntarily participated in and signed informed consent to the hospitalized patients; 7) patients with no severe center of gravity, kidney and liver dysfunction.

Exclusion criteria

Exclusion criteria: 1) inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, psoriasis and so on; 2) 2 or 3 joint chambers were simultaneously involved, and X - ray examination revealed obvious changes in the joint space, and the lateral and lateral subluxation of the joint was more than 3mm; 3) infectious arthritis occurred in the short term before the operation; 4) the patient is mentally incompetent or unable to understand the requirements of participating in the study; 5) known patients have an allergy to one or more implants; 6) severe osteoporosis; 7) there were active infection foci in local or whole body; 8) pregnant women or breast-feeding women; 9) other diseases incorporated by the subjects restricted their participation in the study and were unable to follow up or affect the scientific integrity of the study; 10) refusing to sign a letter of informed consent.

Design outcomes

Primary

MeasureTime frame
American Knee Society Knee Score;

Countries

China

Contacts

Public ContactJiang Qing

Drum Tower Hospital Affiliated to the Medical School of Nanjing University

jiangqing112@hotmail.com+86 13605192953

Outcome results

None listed

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