Prospective Evaluation of Platelet-Rich Plasma and Bone Marrow Concentrate Treatment to Accelerate Healing After Anterior Cruciate Ligament Reconstruction
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Steadman Philippon Research Institute
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects will be included if all the following criteria are met:
- •Age 16-50 years at the time of Anterior Cruciate Ligament Reconstruction (ACLR) surgery;
- •Acute ACL injury within 6 months of scheduled ACLR surgery;
- •Scheduled for unilateral, primary ACLR with a BTB (bone-patellar tendon-bone) autograft;
- •The following concomitant injuries are allowed:
- •Meniscal injuries of all types, grades and regardless of surgical treatment;
- •Articular chondral injury that can be addressed with debridement or chondroplasty;
- •Tibial impaction fractures;
- •Non-operative sprains/injuries of MCL or LCL;
- •Willing and able to comply with all required post-operative visits, biomotion and imaging tests, the self-completion of questionnaires and other trial procedures.
Exclusion Criteria
- •Subjects will be excluded if any of the following criteria are met:
- •Inability to provide informed consent;
- •Women who are pregnant;
- •Previous surgery for either knee except in cases of prior diagnostic arthroscopy and/or minimal debridement;
- •Significant osteoarthritis (OA) of the knee (e.g. grade 4 with cystic changes and/or significant osteophytes);
- •Concomitant cartilage restoration procedure in the operative knee;
- •Biologic treatment (e.g. PRP, BMC, prolotherapy, etc.) in the operative knee within 6 months of ACLR surgery;
- •Steroid injections in the operative knee within 3 months of ACLR surgery;
- •Open growth plates (determined by the treating physician based on standard-of-care preoperative knee radiographs);
- •History of deep vein thrombosis (DVT) or pulmonary embolism (PE) that requires additional anticoagulation beyond usual post-operative standard of care;
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events
Time Frame: 18 months
Occurrence of adverse events
Secondary Outcomes
- Measure signature cellular profile of BMC(Day of Surgery)
- Measure plasma levels of pro-inflammatory factors in BMC(Day of Surgery)
- Measure plasma levels of pro-inflammatory factors in LP-PRP(Day of Surgery)
- Quantitative Magnetic Resonance Imaging (MRI)(screening, baseline; 6 and 12 months post-surgery)
- Patient reported outcome questionnaire(screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery)
- Computerized tomography (CT): 3D geometry of bony anatomy using a series of x-rays(6 months post-surgery)
- Patient Reported Outcome questionnaire(screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery)
- DSX: three dimensional (3D) to measure motion of the knee using dynamix x-ray software(6 and 12 months post-surgery)
- Motion Assessment(screening, baseline; 6 months post-surgery)