Traditional Open Ended Trocar vs. Fenestrated Blunt Trocar in Bone Marrow Aspirate for Osteoarthritis: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Advanced Orthopaedic Specialists
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change in Knee injury and Osteoarthritis Outcome Score (KOOS)
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
Osteoarthritis (OA) is a leading cause of disability around the world. The aging population is only further increasing its prevalence. Moreover, increasing rates of obesity, as well as increasing athletic participation, is leading to patients developing OA at younger ages. Although total joint replacement is effective for alleviating the effects of OA for many patients, it is less beneficial for younger patients given the resultant reduced mobility and the ~15 year life of a total joint replacement. Therefore, new options are needed for OA.
One such option is bone marrow aspirate concentrate (BMAC) injection into the diseased joint. Several recent studies have shown significant symptomatic improvement from this therapy. Now, efforts are needed to better understand how to optimize this therapy, as numerous variables are involved, including: the volume of aspirate, adjuvant, aspiration location or locations, anesthetic, etc. Additionally, several FDA-approved needles are available for the aspiration step. Thus, the purpose of this study is to compare two different styles of FDA-approved needles--an open-ended trocar vs. a fenestrated blunt trocar--with respect to clinical outcomes, cell counts, and colony forming units.
In addition to the comparison arms, taking these two groups together, this study will serve as prospective case series of 30 patients undergoing BMAC injection for knee osteoarthritis without a platelet-rich plasma (PRP) or any other adjuvant/carrier.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, age 18-79
- •Patients have tried at least 6 weeks of conservative therapy including: activity modification, weight loss, brace, NSAIDs, corticosteroid injection
- •Radiographically confirmed Kellgren-Lawrence I-III OA (no bone-on-bone)
- •Patients can provide written informed consent
Exclusion Criteria
- •Clinically and radiologically confirmed anterior/posterior cruciate ligament deficiencies
- •History of meniscal injury other than degenerative meniscal tears
- •Presence of a degenerative meniscal tear causing mechanical symptoms such as locking, buckling, or give-way
- •Major mechanical axis deviation of more than 50% into either compartment (varus or valgus)
- •Intra-articular injection to affected knee within 3 months of intra-articular BMA injection or HA within 6 months
- •Body mass index of 35 or more; 18.5 or less (malnourished)
- •Active infection
- •Ongoing infectious diseases, including HIV and hepatitis
- •Clinically significant diabetes, cardiovascular, hepatic, or renal disease
- •Active malignancy, undergoing treatment, has undergone treatment, or has decline treatment
Outcomes
Primary Outcomes
Change in Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Baseline, 1 week, 6 weeks, 6 months
Will assess for change in patient reported outcome measure that assesses symptoms, stiffness, pain, function, and quality of life from pre-procedure to post-procedure.
Secondary Outcomes
- Change in Visual Analog Pain Scale (VAS) of affected knee(Baseline, 1 week, 6 weeks, 6 months)
- Change in Tegner Score(Baseline, 1 week, 6 weeks, 6 months)
- Visual Analog Pain Scale (VAS) of aspiration site(Baseline (immediately after intervention), 1 week, 6 weeks, 6 months)
- Change in Lysholm Score(Baseline, 1 week, 6 weeks, 6 months)