Percutaneous bone marrow concentrate and platelet products versus exercise therapy for the treatment of rotator cuff tears: a randomized controlled, crossover trial with 2-year follow-up

Abstract

Background: Surgical repair is recommended for the treatment of high-grade partial and full thickness rotator cuff tears, although evidence shows surgery is not necessarily superior to non-surgical therapy. The purpose of this study was to compare percutaneous orthobiologic treatment to a home exercise therapy program for supraspinatus tears.

Methods: In this randomized-controlled, crossover design, participants with a torn supraspinatus tendon received either 'BMC treatment', consisting of a combination of autologous bone marrow concentrate (BMC) and platelet products, or underwent a home exercise therapy program. After three months, patients randomized to exercise therapy could crossover to receive BMC treatment if not satisfied with shoulder progression. Patient-reported outcomes of Numeric Pain Scale (NPS), Disabilities of the Arm, Shoulder, and Hand, (DASH), and a modified Single Assessment Numeric Evaluation (SANE) were collected at 1, 3, 6, 12, and 24 months. Pre- and post-treatment MRI were assessed using the Snyder Classification system.

Results: Fifty-one patients were enrolled and randomized to the BMC treatment group (n = 34) or the exercise therapy group (n = 17). Significantly greater improvement in median ΔDASH, ΔNPS, and SANE scores were reported by the BMC treatment group compared to the exercise therapy group (-11.7 vs -3.8, P = 0.01; -2.0 vs 0.5, P = 0.004; and 50.0 vs 0.0, P < 0.001; respectively) after three months. Patient-reported outcomes continued to progress through the study's two-year follow-up period without a serious adverse event. Of patients with both pre- and post-treatment MRIs, a majority (73%) showed evidence of healing post-BMC treatment.

Conclusions: Patients reported significantly greater changes in function, pain, and overall improvement following BMC treatment compared to exercise therapy for high grade partial and full thickness supraspinatus tears.

Trial registration: This protocol was registered with www.

Clinicaltrials: gov (NCT01788683; 11/02/2013).

Keywords: Autologous orthobiologics; Bone marrow concentrate (BMC); Cell therapy; Exercise therapy; Musculoskeletal pain; Platelet-rich plasma (PRP); Rotator cuff tears; Shoulder.

Fig. 1

Consort flow diagram

Fig. 2

Patient reported outcomes following exercise therapy compared to outcomes following autologous BMC treatment for RC tears. Between group comparisons (A-C) and within patient (patients in exercise group compared to themselves after crossover to BMC) comparisons (D-F) of change in function (ΔDASH), pain (ΔNPS), and percent improvement (SANE) scores at the 3-month follow-up timepoint. Horizontal lines represent median values (n = displayed)

Fig. 3

Patient reported outcomes following autologous BMC treatment for RC tears. Shoulder (A) function (DASH), (B) pain (NPS), and (C) percent improvement (SANE) at baseline and 1-, 3-, 6-, 12-, and 24-month follow-up timepoints. Lines represent median values. Significant improvements compared to baseline (†) and 1- month (‡) follow-up timepoints (p < 0.05)

Fig. 4

Change in patient reported outcomes following autologous BMC treatment for RC tears in comparison to MCIDs. Solid lines represent the median, and the percentage signifies the portion of patients meeting or exceeding the MCID (dashed lines) for (A) function (ΔDASH), (B) pain (ΔNPS), and (C) percent improvement (SANE) change scores at the 24-month follow-up (n = 44)

Fig. 5

Change in patient reported outcomes following autologous BMC treatment for RC tears versus injectate cellularity. Correlations of 24-month change in (A) function (ΔDASH), (B) pain (ΔNPS), and (C) improvement (SANE) with total nucleated cell counts (n = 44)

Fig. 6

MRI-based modified Snyder Classifications of RC tears. Shoulder MRIs pre- and ≥ 12-months post-BMC treatment (n = 37) separated by RC (A) tear severity and (B) tear location