NCT02111057

Brief Summary

Researchers at the Hospital for Special Surgery are trying to learn more about post-operative rheumatoid arthritis flare (RA). This study hopes to understand RA flare after total joint replacement surgery and what the result of flaring is for patients over the 6 weeks post operation. Through this study we aim to describe rates, characteristics, and risk factors of RA flare within 6 weeks of total hip arthroplasty (THA) and total knee arthroplasty (TKA)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2017

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

3.6 years

First QC Date

April 8, 2014

Last Update Submit

October 16, 2019

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisTotal Hip ReplacementFlarePerioperative Outcomes

Outcome Measures

Primary Outcomes (1)

  • Rate of RA Flare at 6 week post surgery

    The primary outcome is the rate of RA flare within 6 weeks of surgery as measured by the Outcome Measures in Rheumatoid Arthritis Clinical Trials(OMERACT) flare questionnaire. For comparison, the rate of RA flare at 1 week post surgery is measured.

    6 weeks

Secondary Outcomes (1)

  • Severity and impact of flares 6 weeks and one year post arthroplasty, using the OMERACT PFQs

    6 weeks and one year

Study Arms (1)

Perioperative RA

Patients with Rheumatoid Arthritis undergoing a primary or secondary total hip replacement, between the ages of 18 and 90.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will comprise of roughly 200 patients with Rheumatoid Arthritis undergoing a total joint replacement.

You may qualify if:

  • Age \>18
  • Patients with Rheumatoid Arthritis undergoing total joint replacement surgery
  • Satisfy American College of Rheumatology(ACR)/European League Against Rheumatism(EULAR) 2010 classification criteria and/or the 1987 RA criteria (see below) and be diagnosed with RA
  • For control subjects: Have OA(Osteoarthritis), SLE(Systemic lupus erythematosus) or other inflammatory arthritis.

You may not qualify if:

  • Diagnosis of any other systemic rheumatic disease
  • Diagnosis of or crystalline arthropathy.
  • Unable to understand or read English.
  • Unable to follow the study protocol in a reliable manner.
  • Age \< 18 or \>75.
  • EXPLANATION OF CRITERIA:
  • Rheumatoid arthritis 1987 criteria:
  • morning stiffness in and around joints lasting at least 1 hour before maximal improvement;
  • soft tissue swelling (arthritis) of 3 or more joint areas observed by a physician;
  • swelling (arthritis) of the proximal interphalangeal, metacarpophalangeal, or wrist joints;
  • symmetric swelling (arthritis);
  • rheumatoid nodules;
  • the presence of rheumatoid factor; and
  • radiographic erosions and/or periarticular osteopenia in hand and/or wrist joints.
  • ACR/EULAR 2010 criteria for the classification of RA:
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

During surgery, the subjects' surgeon will take samples of the tissue removed as part of their surgery from their joint. Specifically for Total Hip Replacement (THR), the femoral head will be collected intraoperatively from standardized anatomic sites, (fovea and capsular reflection). For Total Knee replacement (TKR), tissue samples of the patella cartilage, distal femur and proximal tibia, and synovium from the suprapatellar pouch will be collected intraoperatively.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 10, 2014

Study Start

October 16, 2013

Primary Completion

May 9, 2017

Study Completion

May 9, 2017

Last Updated

October 21, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)