- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00961623
Characterizing Knee Pain and Response to Surgery Using Local Biomarkers
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Kontakter och platser
Studieorter
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California
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Stanford, California, Förenta staterna, 94305
- Stanford University School of Medicine
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Surgical outcome: pain and functionality
Tidsram: 12-24wk post-operative.
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12-24wk post-operative.
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Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Expression profiles of inflammatory mediators
Tidsram: 24wk
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24wk
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Jason L Dragoo, MD, Stanford University
- Studiestol: Eric Leroux, Stanford University
- Studiestol: Amy Wasterlain, Stanford University
- Huvudutredare: Gaetano Scuderi, MD, Stanford University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SU-07292009-3441
- IRB 16305 (Annan identifierare: Stanford IRB)
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