Arthroscopic Synovectomy Combined With DMARDs in the Treatment of Refractory Elbow Rheumatoid Arthritis

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04454034

Enrollment

Registered

2020-07-01

Start date

2019-08-01

Completion date

2021-12-31

Last updated

2021-06-28

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

Conditions

Rheumatoid Arthritis of Ankle

Keywords

Rheumatoid Arthritis, Arthroscopic Synovectomy

Brief summary

Rheumatoid arthritis (RA) is an autoimmune disease characterized by chronic and aggressive polyarthritis. The prevalence of RA in China is about 0.42%. Arthroscopic synovectomy (AS) is an important method to save the function of joint in the treatment of refractory RA. The clinical trial is to study the value of AS combine with DMARDs in the early stage of refractory RA.

Interventions

PROCEDUREarthroscopic synovectomy

arthroscopic synovectomy

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Inclusion criteria

* The patients who fulfilled the 1987 ACR（American College of Rheumatology) or 2010 ACR/EULAR（European League Against Rheumatism） RA classification criteria. * The age is more than 18 years old and less than 60 years old. * They received stable traditional DMARDs (including Chrysopidae, leflunomide, sulfasalazine, hydroxychloroquine, eilamod) or biological dmrads (including tumor necrosis factor antagonists, IL(Interleukin)-6 receptor antagonists, CD20 monoclonal antibodies) for at least 6 months. * The disease is still in the active stage, which means the disease activity score (DAS28) is more than 3.2, and the elbow joint function is obviously limited. * The patient agreed to undergo arthroscopic synovectomy. * No contraindications were found.

Exclusion criteria

* The disease is in remission. * The patient has contraindications. * Arthroscopic synovectomy was performed in different patients.

Design outcomes

Primary

Measure	Time frame	Description
ACR70 remission	6 months after surgery	the percent of patients who meet ACR70 remission

Secondary

Measure	Time frame	Description
Disease Activity Score (DAS) 28-erythrocyte sedimentation rate (ESR) (range 0-9.4)	1,3,6 and 12 months after surgery	Remission: 2.6 Low activity: 2.6 to ,3.2 Moderate activity: 3.2 to 5.1 High activity: .5.1
tender joint count	1,3,6 and 12 months after surgery	the number of tender joints
swollen joint count	1,3,6 and 12 months after surgery	the number of swollen joints

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026