Characterizing Knee Pain and Response to Surgery Using Local Biomarkers - Full Text View

Sponsor:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00961623

Purpose

The diagnosis and monitoring of clinically-significant pathologies of the knee remains challenging, and it is unknown why only some injuries become painful or respond to surgical intervention. The limitations of diagnostic magnetic resonance imaging result in arthroscopy that is not always beneficial. Elucidation of biochemical pathways underlying pain in this condition may aid patient selection for surgery and provide pharmacotherapeutic targets. Cytokines or a novel yet uncharacterized protein may be involved in pain following meniscus injury and diagnostic cytokine assay may help physicians differentiate patients that may benefit from arthroscopy from those that may not. Additionally, evaluating post-operative biochemical profiles may provide a method of monitoring surgical outcome and understanding post-operative continuation or remission of pain.

Condition
Inflammation

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Characterizing Knee Pain and Response to Surgery Using Local Biomarkers

Further study details as provided by Stanford University:

Primary Outcome Measures:

Surgical outcome: pain and functionality [ Time Frame: 12-24wk post-operative. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Expression profiles of inflammatory mediators [ Time Frame: 24wk ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Synovial fluid lavage.

Estimated Enrollment:	150
Study Start Date:	July 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Detailed Description:

Lavage of the operative and contralateral knee for comparison are performed under anesthesia prior to arthroscopy by the infusion of 10cc sterile saline into the knee joint followed by the immediate withdrawal into the syringe, and storage at -80°C in a tube containing a protease inhibitor. At 12wk post-operative a 10cc lavage is performed on the knee that underwent surgery. Clinical findings for each sample are quantified using gold-standard symptom severity questionnaires.

The specimens will be analyzed for 31 potential biomarkers using a multiplexed immunoassay panel, the results of which will be compared with pre- and post-operative clinical findings and radiographic imaging. Plans do not currently include microarray analysis, but this may be later included.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Our study population includes adult males and females presenting to a single orthopaedic surgeon for arthroscopic management of acute or chronic knee pain due to a mechanical derangement discernable by MRI.

Subjects are selected using a probability sampling scheme, such that every knee arthroscopy patient that presents, without exclusionary criteria described above, is offered enrollment in the study. To date, approximately 85% of patients consent to enrollment, with no apparent sampling bias. Additionally, we are using repeated measures (matched random sampling) to evaluate the role of mediators of knee pain, and to assess the potential of utilizing expression profiles to monitor surgical outcome. For example, clinical indicators and biomarker expression profiles taken peri-operatively are compared to those obtained 12 weeks post-operatively in the same subject.

Criteria

Inclusion Criteria:

•Adult patients with knee pain (acute or chronic) who had failed conservative treatment and elected for arthroscopic management. Indications for surgery included the presence of mechanical symptoms on history, a physical examination positive for McMurray's maneuver or joint line tenderness or both, absence of severe joint space narrowing on plain radiography, and the presence of grade III signal changes on MRI in an anatomic location consistent with the history and physical examination.

Exclusion Criteria:

Less than 18 years old.
Recent (within three months) intra-articular corticosteroid injection and past or current medical history of autoimmune disease (i.e. rheumatoid arthritis).
In addition, no patients involved in a worker's compensation claim or personal injury litigation were enrolled in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961623

Contacts

Contact: Eric Leroux

(917) 428-3991

eleroux@stanford.edu

Locations

United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Eric Leroux 917-428-3991 eleroux@stanford.edu
Sub-Investigator: Eric Leroux
Principal Investigator: Dr. Jason L. Dragoo

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:	Jason L Dragoo, MD	Stanford University
Study Chair:	Eric Leroux	Stanford University
Study Chair:	Amy Wasterlain	Stanford University
Principal Investigator:	Gaetano Scuderi, MD	Stanford University

More Information

No publications provided

Responsible Party:	Dr. Jason L. Dragoo, Stanford University School of Medicine
ClinicalTrials.gov Identifier:	NCT00961623 History of Changes
Other Study ID Numbers:	SU-07292009-3441, IRB 16305
Study First Received:	August 17, 2009
Last Updated:	June 10, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012