ABSTRACT
Background Anterior cruciate ligament (ACL) injury is most common among athletes compared to the general population. ACL reconstruction is a clinical standard for restoring joint mechanical stability and enabling sports return. The purpose of the study is to evaluate the safety and functional outcomes after arthroscopic ACL reconstruction using the Sironix titanium button and the polyetheretherketone (PEEK) button. Methods A total of 31 subjects who have undergone arthroscopic ACL reconstruction using the Sironix titanium button and PEEK button between August 2022 and January 2023 were included in the study. Demographic data, surgery details, and other baseline characteristics of the subjects were collected from the hospital records. The primary objective of the study was to assess the functional outcome using the International Knee Documentation Committee (IKDC) questionnaire. The secondary objectives were to determine the pre- and post-surgery activity levels using the Tegner Activity Score (TAS) and Lysholm score. Quality of life evaluation was done by using the Quality of Life (QoL) subscale from the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Single Assessment Numerical Evaluation (SANE). Device-related adverse effect information was recorded. Results The mean (SD) of the total IKDC score of 31 subjects at baseline and post-surgery was 51.4 (2.84) and 91.8 (2.59) out of 100, respectively. The mean (SD) of TAS pre-injury and post-surgery was 5.3 (1.47) and 5.4 (1.38) out of 10, respectively. The total mean (SD) value of the total Lysholm Score at baseline and post-surgery was 53.9 (3.72) and 91.4 (3.61) out of 100, respectively. The mean (SD) value of the quality of life subscale of the KOOS score was 91.2 (3.91) out of 100. The total mean (SD) value of the SANE score that had affected joint/region of interest today was 97.4 (1.78), while for the opposite side today, it was 99.5 (0.85) out of 100. There were no adverse device effects reported in this study. Conclusion Based on the score assessment, it was observed that the performance of Sironix knee implant devices, Proloop-Titanium adjustable loop button, T-Button A® Closed PEEK button, and Surestitch® All Inside Meniscal Repair Implant (Healthium Medtech Limited, Bengaluru, Karnataka, India) was effective and safe with no adverse effects. Therefore, Sironix knee implants are considered safe and effective in ACL reconstruction and meniscus repair surgery.
ABSTRACT
Introduction The meniscus plays a vital role in maintaining knee stability. It acts as a shock absorber and knee filler. The incidence of meniscal tears is estimated to be 60 per 100,000 people. Due to lack of awareness among patients, only 10% of the meniscus tears were treated through partial or total meniscectomy. Recently, the concept of meniscus preservation surgery has emerged to preserve early degeneration of the knee joint. In the current retrospective study, safety and functional outcomes of arthroscopic meniscal repair surgery using Surestitch All inside implants (Sironix Arthroscopy Solutions, Healthium Medtech Limited, Bengalaru, India) were assessed. Methods Fifty-two patients who underwent arthroscopic meniscal repair surgery between January 2019 to July 2022 at Epic Hospital in Gujarat, India, were enrolled in the study. Retrospective data including demographics, injury details, surgery details, and post-surgery complications were collected from the medical records of the patients. Then, the patients were followed up telephonically to document safety and functional outcomes using patient-reported instruments such as International Knee Documentation Committee (IKDC) score, Single Assessment Numeric Evaluation (SANE) score, Tegner activity level, and Lysholm knee score. Results The recruited patients had the mean age, height, and weight of 37.56 ± 12.52 years, 167.61 ± 7.28 cm, and 75.87 ± 10.7 kgs, respectively. Seventy-one percent of patients were male and 29% were female. Majority of the patients had the routine of doing mild exercise. During pre-surgery representations, medial meniscal tear was observed in majority of patients. The mean length of the tear was 1.32 ± 0.84 cm. In addition, patients were also diagnosed with anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL) tears, and osteochondral defects. Surgeries for meniscal repair were performed using Surestitch All inside implant. In patient-reported outcomes, the mean IKDC, SANE, and Lysholm scores were 81.72 ± 14.23, 94.02 ± 13.79, and 93.32 ± 14.63, respectively. When the mean Tegner scores of pre-injury and post-surgery periods were compared, this resulted in no significant difference (p>0.05) in the activity levels of the patients. Conclusion Based on our findings, arthroscopic meniscal repair with Surestitch All inside meniscal repair implant provides satisfactory and favorable functional outcomes with no remarkable adverse events.
ABSTRACT
Background Rotator cuff tears (RCTs) are the most common cause of shoulder disability. RCT is characterized by progressive wear and tear of the tendon tissue over time. The incidence of cuff tears ranges from 5% to 39%. With increasing advancements in the surgical sector, an upward trend has been observed in repair surgeries where torn tendons are repaired arthroscopically by inserting surgical implants. With this background, this study aimed to assess the safety, efficacy, and functional outcomes after RCT repair using Ceptre® titanium screw anchor implants. Methodology This retrospective, observational, single-center, clinical study was conducted at Epic Hospital in Gujarat, India. Patients who underwent rotator cuff repair surgery between January 2019 and July 2022 were recruited and followed up in December 2022. Baseline characteristics and surgical and post-surgical details were collected from patient medical reports and post-surgery progress data were documented through telephonic follow-up. The functional outcomes and efficacy of the implant were assessed using the American Shoulder and Elbow Surgeons (ASES) form, Shoulder Pain and Disability Index (SPADI) score, Simple Shoulder Test (SST), and Single Assessment Numeric Evaluation (SANE) score. Results The mean age of the recruited patients was 59.74 ± 8.91 years. Among the recruited patients, 64% were females and 36% were males. About 85% of patients had a right shoulder injury and 15% of patients (n = 6/39) had a left shoulder injury. Further, 64% (n = 25/39) of patients had supraspinatus tears, whereas 36% (n = 14) of patients had both supraspinatus and infraspinatus tears. The mean ASES, SPADI, SST, and SANE scores were observed to be 81.43 ± 14.20, 29.41 ± 12.6, 75.41 ± 12.96, and 94.67 ± 7.50, respectively. No adverse events, re-injuries, or re-surgeries were reported by any of the patients during the study period. Conclusions Our findings suggest that arthroscopic rotator cuff repair using Ceptre Knotted Ultra-High-Molecular-Weight Polyethylene Suture Titanium Screw Anchor resulted in favorable functional outcomes. Thus, it could be a considerable implant for a successful surgery.
