This is a prospective, randomized, placebo-controlled trial to evaluate potential beneficial effects of leukocyte-poor platelet rich plasma and bone marrow concentrate on the healing and health of critical joint tissues in the knee following anterior cruciate ligament (ACL) reconstruction. Bone marrow contains stem cells which can change into cells of various different tissue types, while platelet rich plasma contains growth factors. This trial will compare the two procedures against placebo.
This is a prospective, randomized, placebo-controlled trial. Patients will be randomized into three groups: Concentrated Bone Marrow Concentrate (BMC), Platelet-Rich Plasma (PRP) or Placebo. BMC subjects will have bone marrow aspirated from the subjects iliac crests and the cellular rich portion will be concentrated and subsequently injected into the subjects' symptomatic knee during ACL reconstruction surgery. PRP subjects will have a venous blood draw and the resulting PRP will be injected into the symptomatic knee during ACL reconstruction surgery. Follow-up visits in person will take place at 2 weeks, 6 months and 12 months after the ACL reconstruction surgery. The purpose of this study is to evaluate potential beneficial effects of leukocyte-poor platelet-rich plasma (LP-PRP) and bone marrow concentrate (BMC) on the healing and health of all critical joint tissues (grafts/ligaments, meniscus and cartilage) in the knee following anterior cruciate ligament reconstruction (ACLR). Key aspects of this proposal include our well-developed methodologies to quantify and correlate cytokines, chemokines, growth factors in PRP and progenitor cells in BMC, clinical outcomes and imaging following ACLR. The overarching goal of this randomized control trial is to establish a biological signature of PRP and BMC that will be indicative for optimal recovery after ACLR. The long-term goal of our research is to better understand the efficacy of orthobiologic approaches to improve clinical outcomes, enhance graft healing and mitigate post-traumatic osteoarthritis (PTOA) in a cohort of patients that have undergone ACLR.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
Participants will have a knee injected with Platelet-Rich Plasma (PRP) obtained from a venous whole blood draw from the vein.
Participants will have a knee injected with BMC stem cells harvested from the iliac crest
Participants will undergo ACLR surgery with no injection into their knee.
181 West Meadow Drive, Suite 1000
Vail, Colorado, United States
Incidence of Treatment-Emergent Adverse Events
Occurrence of adverse events
Time frame: 18 months
Patient reported outcome questionnaire
SF-12 Short Form General Health Survey Patient Satisfaction
Time frame: screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery
Measure signature cellular profile of BMC
Flow cytometer to analyze BMC cell concentrations
Time frame: Day of Surgery
Measure plasma levels of pro-inflammatory factors in BMC
Multiplex analysis of pro-inflammatory cytokines and chemokines using Luminex 200®
Time frame: Day of Surgery
Measure plasma levels of pro-inflammatory factors in LP-PRP
Multiplex analysis of pro-inflammatory cytokines and chemokines using Luminex 200®
Time frame: Day of Surgery
Quantitative Magnetic Resonance Imaging (MRI)
Images acquired on a 3T Siemens Magnetom Skyra-fit scanner
Time frame: screening, baseline; 6 and 12 months post-surgery
DSX: three dimensional (3D) to measure motion of the knee using dynamix x-ray software
Up to three brief X-ray exposures (6 scouts x 3 frames and 2 statics x 5 frames and 24 exposures x 100 frames will be acquired)
Time frame: 6 and 12 months post-surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
SINGLE
Enrollment
45
Computerized tomography (CT): 3D geometry of bony anatomy using a series of x-rays
single, bilateral knee CT scan using Toshiba Aquilon Premium 160 CT scanner
Time frame: 6 months post-surgery
Patient Reported Outcome questionnaire
IKDC - International Knee Documentation Committee Score
Time frame: screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery
Patient Reported Outcome questionnaire
WOMAC - Western Ontario \& McMaster Universities Osteoarthritis Index
Time frame: screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery
Patient Reported Outcome questionnaire
Lysholm Score
Time frame: screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery
Patient Reported Outcome questionnaire
Tegner Activity Scale
Time frame: screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery
Patient Reported Outcome questionnaire
NRS (NUMERICAL RATING SCALE) for Pain
Time frame: screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery
Motion Assessment
3D video motion capture
Time frame: screening, baseline; 6 months post-surgery