Investigation of Specific Protein/Markers in Patients With Osteoarthritis of the Knee Having a Total Knee Replacement

NCT ID: NCT01611441

Last Updated: 2012-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main purpose of the study is to better understand how specific proteins/markers in blood, urine, synovial fluid (a lubricating fluid secreted by the membrane lining the joints), and joint tissue are involved in osteoarthritis of the knee. The aim is to investigate if there is a correlation between x-ray results, specific proteins/markers and different types of pain in patients with osteoarthritis of the knee. The study consists of 3 visits over 3-20 days and the last visit will be the day of surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Investigation of Biomarkers in an Exploratory Study in Patients with Osteoarthritis of the Knee Undergoing Total Knee Replacement Surgery

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis of the Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with osteoarthritis of the knee

Patients with osteoarthritis of the knee undergoing total knee replacement surgery.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who will undergo a total knee replacement due to osteoarthritis.
* Symptoms of the knee for at least 6 months prior to study start.

Exclusion Criteria

* Key-hole surgery performed on target knee within 3 months prior to study start.
* History of disorders in which part of the immune system is missing or defective.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rolf Karlsten, MD, PHD

Role: STUDY_DIRECTOR

AstraZeneca R&D Sodertalje, Sweden

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Montreal, , Canada

Site Status

Research Center

Newmarket, , Canada

Site Status

Research Site

Québec, , Canada

Site Status

Research Site

Kungälv, , Sweden

Site Status

Research Site

Motala, , Sweden

Site Status

Research Site

Stockholm, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Radojcic MR, Thudium CS, Henriksen K, Tan K, Karlsten R, Dudley A, Chessell I, Karsdal MA, Bay-Jensen AC, Crema MD, Guermazi A. Biomarker of extracellular matrix remodelling C1M and proinflammatory cytokine interleukin 6 are related to synovitis and pain in end-stage knee osteoarthritis patients. Pain. 2017 Jul;158(7):1254-1263. doi: 10.1097/j.pain.0000000000000908.

Reference Type DERIVED
PMID: 28333699 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D2285M00029

Identifier Type: -

Identifier Source: secondary_id

D2285M00029

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

10003 PRO Current Products
NCT01497730 COMPLETED
Evaluation of Biomarkers in Human Synovial Fluid
NCT02664870 ACTIVE_NOT_RECRUITING