None listed
Conditions
Brief summary
The objective of this study is to assess the tendon healing rates and clinical outcomes of arthroscopic rotator cuff repair (aRCR). This randomised control trial (RCT) will compare the standard aRCR (Control group) with two treatment groups, aRCR augmented with either intra-operative administration of concentrated bone marrow aspirate (cBMA) or leukocyte-poor platelet rich plasma (LP-PRP). We hypothesise that augmented rotator cuff repair will result in statistically significant benefits for rotator cuff healing on ultrasound and MRI as well as clinical shoulder scores.
Interventions
Arthroscopic rotator cuff repair with
1) leukocyte poor platelets rich plasma using Arthrex ACP® Double-Syringe System with approximately 50mL of blood aspirate or
2) concentrated bone marrow aspirate using Angel® cPRP and Bone Marrow Processing System using approximately 50mL of bone marrow aspirate or
3) COMPARATOR -nil augmentation.
The orthobiologic augmentation will be delivered via syringe directly to the footprint site of the rotator cuff repair and documented on the collection data s
Arthroscopic rotator cuff repair with 1) leukocyte poor platelets rich plasma using Arthrex ACP® Double-Syringe System with approximately 50mL of blood aspirate or 2) concentrated bone marrow aspirate using Angel® cPRP and Bone Marrow Processing System using approximately 50mL of bone marrow aspirate or 3) COMPARATOR -nil augmentation. The orthobiologic augmentation will be delivered via syringe directly to the footprint site of the rotator cuff repair and documented on the collection data sheet. The rotator cuff repair will be performed by the consultant surgeon at registered site with approx 1hr duration. Records for each case will be recorded by the treating team to ensure adherence to the intervention.
Sponsors
The Orthopaedic Research Institute of Queensland Mater Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- Patient aged between 18-75 undergoing primary arthroscopic rotator cuff repair (aRCR) - Symptomatic rotator cuff tear confirmed on pre-op MRI (small to massive)
Exclusion criteria
- Previous rotator cuff surgery - Glenohumeral joint arthritis - Inflammatory arthropathy - Instability - History of platelet rich plasma injection, bone marrow aspirate injection or other biologic injections in the past 12 months - Significant psychiatric disorder - Cognitive impairment - Current drug and alcohol abuse - Active acute or chronic infection - Inability to consent
Outcome results
None listed