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Characterizing Knee Pain and Response to Surgery Using Local Biomarkers

Characterizing Knee Pain and Response to Surgery Using Local Biomarkers

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00961623
Enrollment
0
Registered
2009-08-19
Start date
2009-07-31
Completion date
2011-12-31
Last updated
2019-06-04

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

Conditions

Inflammation

Brief summary

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.

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.

Interventions

None listed

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Surgical outcome: pain and functionality12-24wk post-operative.

Secondary

MeasureTime frame
Expression profiles of inflammatory mediators24wk

Countries

United States

Outcome results

None listed

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