Randomized Controlled Prospective Trial For Rotator Cuff Tear Repair With Medialized Single Row Suture Anchors And Augmentation With Porcine Dermal Patch
Rotator cuff tear repair is still affected by a high rate of not healing at 6 months follow up. Most of this variability can be explained by the different study populations in terms of age, type of lesion, and surgical technique, leading to a difficult understanding of the real technical and biological advantages of the several types of repair. For this purpose the present RCT was elaborated; strict inclusion and exclusion criteria were applied in order to select very homogeneous patients, candidate for an arthroscopic cuff tear repair, aiming at evaluating the anatomical integrity of the repairs done with a medialized single row suture anchor technique and a porcine dermal patch augmentation versus the same repair without the biological augmentation. The main hypothesis was that the biological augmentation would lead to a higher rate of healing, by means of tendon-to-bone integration, with a wider footprint extension, better strength recovery, and a higher quality repaired tissue.
Materials And Methods
Study population resulted in 96 total patients: group A underwent the augmentation repair, group B underwent a standard repair. After inclusion and exclusion criteria were met, randomization was carried on. Surgery was standardized: all patients were treated arthroscopically for a medialized single row repair, associated to biceps tenotomy and acromionplasty. Augmentation patch was applied in group A after appropriate measurement, with 2 medial simple stiches and 2 lateral TOE suture anchors, according to the Goal Post Technique.
Evaluation, at t0 and at the follow ups, was performed with Constant, Dash, VAS, and SST scores, and radiologically, with standard 4 views XR study, and high field MRI for the assessment of lesion extension, tendon thickness, and signal intensity. Isometric tests were also performed. Follow-up were set at 1-3-6-12-24 months.
The present paper shows the outcomes obtained up to the 12 months follow-up, reached by all patients. At the one year follow up, the healing rate was slightly better, favoring the augmented group with the 84.5% of the cases that healed properly; if the thinned but completed tendons are added in the computing, the total healing rate reaches 96.7%. In comparison, not augmented group resulted in a total of 66,7% of healed cases, with only the 44,4% that healed properly. Mann-Whitney test reported a p<0,005, demonstrating a proper recreation of an anatomical footprint in favor of the augmented group. ROM and strength were recovered by almost every patient, and only 1 of them developed a complication, namely a pull out of a TOE anchor due to trauma.
All the scores submitted resulted in statistically significant improvement as well, more intense for the augmented group.
The present paper demonstrates a real efficacy for biological augmentation in rotator cuff repairs compared to standard repairs. The improvement offered by this porcine patch is exerted shortly after the surgery and is maintained up to 12 months, offering excellent results in terms of clinical objectivity, strength, patients’ satisfaction, and MRI evidences.