Functional and radiologic results of the crimson duvet procedure in rotator cuff treatment: a randomized controlled clinical trial.

Abstract

Rotator cuff tears are one of the more frequent pathologies of the shoulder. Arthroscopic techniques and biologic augmentation have been developed to improve the rate and quality of healing. The crimson duvet procedure (CDP) theoretically provides mesenchymal stem cells through microfracture treatment of the footprint. The aim of this research was to evaluate the effect of CDP in patients who had undergone arthroscopic surgery for complete rotator cuff repair. A prospective randomized clinical trial was performed in a total of 123 patients, consisting of 59 women and 64 men, with a mean age of 58 years. We included patients with a clinical and radiologic diagnosis of a complete rotator cuff tear. All patients were treated with arthroscopic rotator cuff repair. In group 1, the surface of the footprint was débrided; in group 2, the footprint underwent microfracture. The primary outcome was the nonhealing rate, which was detected by magnetic resonance imaging (MRI) or ultrasonography, and the secondary outcome was the functional result. A Sugaya classification of I to III was considered to indicate healing. For clinical evaluation, the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) and Constant scores were evaluated, along with the range of motion. The functional evaluation was performed preoperatively and at 6 months and 1 year postoperatively. The radiologic (MRI or ultrasonography) evaluation was performed at 6 months. Neither the patients nor the radiologists and physical therapists who performed the postoperative evaluations were informed of the random selection. We observed a healing rate of 85.11% in the control group and 93.7% in the CDP group, which was not significant (P=.19). However, a significant improvement in function was observed in all patients. The ASES score improved from 68.9 (SD 13.8) preoperatively to 92.2 at 6 months and to 96.4 (SD 6.2) at 12 months (P<.05), but no difference was observed between the groups. A similar level of improvement was observed in the Constant score. The arthroscopic repair of complete rotator cuff tears presents good and excellent clinical results in most patients. Nevertheless, nonhealing occurs at a rate that depends mainly on the age of the patient and the size of the tear. The addition of CDP did not improve the functional results or the healing rate.