Cole (2023) — Prospective Randomized Trial of Biologic Augmentation With Bone Marrow Aspirate Concentrate in Patients Undergoing Arthroscopic Rotator Cuff Repair.

Prospective Randomized Trial of Biologic Augmentation with Bone Marrow Aspirate Concentrate in Patients Undergoing Arthroscopic Rotator Cuff Repair.

·Am J Sports Med·2023·62 citations·Shoulder & Elbow

First prospective RCT comparing arthroscopic rotator cuff repair with vs. without concentrated bone marrow aspirate (cBMA) augmentation in patients with isolated 1–3 cm supraspinatus tears. Assesses patient-reported outcomes over 2 years and structural integrity on 1-year MRI using Sugaya classification.

Study Snapshot

Design

Single-center RCT

Blinding: Single-blind

Setting: Single center, Chicago

Funding: Industry (Arthrex)

Objective

Determine whether bone marrow aspirate concentrate augmentation improves arthroscopic rotator cuff repair outcomes

Outcome(s)

ASES score improvement at 2 years postoperatively

Subjects

91 patients (cBMA n=46, control n=45)

46cBMA injection at repair site after arthroscopic RCR
45Sham 0.5-cm hip incision + arthroscopic RCR alone

Inclusion

Age 18–70, primary arthroscopic RCR
1–3 cm full-thickness supraspinatus tear on MRI

Exclusion

Tear >3 cm or multiple tendons involved
Previous rotator cuff repair
Prior biologic injection ipsilateral shoulder <12 months

Follow-up

Minimum 2 years (mean 3.24 years)

Statistics

Mann-Whitney UWilcoxon signed-rankFisher's exact testUnivariate logistic regression

Key Findings

cBMA augmentation cut MRI-detected retear by two-thirds at 1 year, yet this structural gain produced no clinical payoff — the defining paradox of this trial:
–57% Sugaya 4/5 in controls vs 18% in cBMA group* (P < .001, OR 0.17)
–Mean Sugaya score: controls 3.43 ± 1.04 vs cBMA 2.63 ± 0.91
Treatment failure rates were statistically identical despite the dramatic imaging difference — 16% control (7/45) vs 15% cBMA (7/46) (P = .964) — suggesting MRI retear and clinical failure are not interchangeable endpoints
Patient-reported outcomes improved robustly in both groups by 6 months and held through 2 years on ASES, SANE, and Simple Shoulder Test, with no between-group difference at any time point (2-year ASES: P = .699)
MSC delivery was highly variable:
–Mean 44
–114 MSCs/mL but range **4
–045–272
–971 MSCs/mL** — a >60-fold spread that may have diluted any true biologic dose-response effect
cBMA improved internal and external rotation strength at 1 year vs baseline, but only internal rotation in 90° abduction differed significantly from controls — a modest and clinically uncertain strength advantage

Clinical Relevance

When counseling patients on cBMA augmentation for small-to-medium rotator cuff repairs, recognize that it significantly reduces radiographic retear rates but does not improve functional outcomes or treatment failure at 2 years — the added cost and iliac crest morbidity are not justified by short-term clinical gains, though longer follow-up may yet reveal benefit from superior structural healing.

Supplemental

Prospective Randomized Trial of Biologic Augmentation with Bone Marrow Aspirate Concentrate in Patients Undergoing Arthroscopic Rotator Cuff Repair.

Cole, Verma, et al.·Am J Sports Med·2023·62 citations·Shoulder & Elbow

Prospective Randomized Trial of Biologic Augmentation with Bone Marrow Aspirate Concentrate in Patients Undergoing Arthroscopic Rotator Cuff Repair.

Study Snapshot

Key Findings

Clinical Relevance

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Prospective Randomized Trial of Biologic Augmentation with Bone Marrow Aspirate Concentrate in Patients Undergoing Arthroscopic Rotator Cuff Repair.

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Prospective Randomized Trial of Biologic Augmentation with Bone Marrow Aspirate Concentrate in Patients Undergoing Arthroscopic Rotator Cuff Repair.

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Key Findings

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Prospective Randomized Trial of Biologic Augmentation with Bone Marrow Aspirate Concentrate in Patients Undergoing Arthroscopic Rotator Cuff Repair.

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Key Findings

Clinical Relevance

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