An All-Suture Anchor Offers Equivalent Clinical Performance to an Established Solid Suture Anchor in the Arthroscopic Repair of Rotator Cuff Tears: A Prospective, Randomized, Multicenter Trial With 12-Month Follow-Up.
Arthroscopy
; 40(2): 265-276, 2024 02.
Article
em En
| MEDLINE
| ID: mdl-37423469
ABSTRACT
PURPOSE:
To evaluate the safety and efficacy of a next-generation, all-suture anchor in patients undergoing arthroscopic repair of rotator cuff tears, compared with that of an established solid suture anchor.METHODS:
Between April 2019 and January 2021, a prospective, comparative, randomized controlled noninferiority study conducted on people with Chinese ethnicity at 3 tertiary hospitals enrolled patients (18-75 years) requiring arthroscopic treatment for rotator cuff tears. Patients were randomized into 2 cohorts receiving either all-suture anchor or solid suture anchor and followed for 12 months. The primary outcome was the Constant-Murley score at the 12-month follow-up. Magnetic resonance imaging assessments determined the rate of retear of rotator cuff repair (defined as Sugaya classification 4 and 5). Safety evaluation was performed at all follow-up points to determine the adverse events (AEs).RESULTS:
In total, 120 patients with rotator cuff tears (mean age, 58.3 years; 62.5% female; 60 receiving all-suture anchor) underwent treatment. Five patients were lost to follow-up. Both cohorts showed significant improvement in Constant-Murley scores between baseline and 6 months (P < .001) and between 6 and 12 months (P < .001). There were no significant differences in Constant-Murley scores between the 2 cohorts at 12 months (P = .122) after operation. The retear rate at 12 months was 5.7% and 1.9% in the all-suture and solid suture anchor cohorts, respectively (P = .618). There were 2 cases of intraoperative anchor pullout, both of which were successfully resolved. No cases of postoperative reoperation or other anchor-related AEs were reported.CONCLUSIONS:
The all-suture anchor offered equivalent clinical performance to an established solid suture anchor at the 12-month follow-up in patients undergoing arthroscopic repair of rotator cuff tears. The retear rate was not statistically significantly different between the 2 cohorts. LEVEL OF EVIDENCE Level I, randomized controlled trial.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Lesões do Manguito Rotador
Tipo de estudo:
Clinical_trials
Limite:
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article