Correction to: Long-term safety and clinical performance of kyphoplasty and SpineJack® procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study.

The author list was incomplete. The complete list of authors is the following: D. Noriega, F. Rodrίguez-Monsalve, R. Ramajo, I.Sánchez-Lite, B. Toribio, F. Ardura. The corresponding author regrets sincerely this error. The original article got update.

Long-term safety and clinical performance of kyphoplasty and SpineJack® procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study.

This pilot monocenter study in 30 patients with painful osteoporotic vertebral compression fractures compared two vertebral augmentation procedures. Over a 3-year post-surgery follow-up, pain/disability/quality of life remained significantly improved with both balloon kyphoplasty and SpineJack® techniques, but the latter allowed better vertebral body height restoration/kyphosis correction. INTRODUCTION: Patient follow-up rarely exceed 2 years in trials comparing vertebral augmentation procedures for the treatment of painful osteoporotic vertebral compression fractures (VCFs). This pilot, investigator-initiated, prospective study aimed to compare long-term results of SpineJack® (SJ) and balloon kyphoplasty (BKP). Preliminary results showed that SJ resulted in a better restoration of vertebral heights and angles, maintained over 12 months. METHODS: Thirty patients were randomized to SJ (n = 15) or BKP (n = 15). Clinical endpoints were analgesic consumption, back pain intensity (visual analog scale (VAS)), the Oswestry Disability Index (ODI), and quality of life (EQ-VAS score). They were recorded preoperatively, at 5 days (except EQ-VAS), 1, 3, 6, 12, and 36 months post-surgery. Spine X-rays were taken 48 h prior to the procedure and 5 days, 6, 12, and 36 months after. RESULTS: Clinical improvements were observed with both procedures over the 3-year period without significant inter-group differences, but the final mean EQ-5Dindex score was significantly in favor of the SJ group (0.93 ± 0.11 vs 0.81 ± 0.09; p = 0.007). Vertebral height restoration/kyphotic correction was still evident at 36 months with a greater mean correction of anterior (10 ± 13% vs 2 ± 8% for BKP, p = 0.007) and central height (10 ± 11% vs 3 ± 7% for BKP, p = 0.034) and a larger correction of the vertebral body angle (- 5.0° ± 5.1° vs 0.4° ± 3.4°; p = 0.003) for SJ group. CONCLUSIONS: In this study, both techniques displayed very good long-term clinical efficiency and safety in patients with osteoporotic VCFs. Over the 3-year follow-up, vertebral body height restoration/kyphosis correction was better with the SpineJack® procedure.

Safety and clinical performance of kyphoplasty and SpineJack(®) procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study.

UNLABELLED: Clinical performance and safety of two percutaneous vertebral cement augmentation (VA) procedures (SpineJack® and Kyphx Xpander® balloon) were compared in patients with osteoporotic compression fractures. Both techniques were safe, efficient, and led to a rapid and marked improvement in clinical signs; nevertheless, SpineJack showed better restoration of vertebral heights and angles, maintained over time. INTRODUCTION: In patients with osteoporotic vertebral compression fractures (VCFs), both SpineJack® (SJ) and balloon kyphoplasty (BKP) led to a rapid and marked improvement in clinical signs. This pilot, monocentric, investigator-initiated, prospective study aimed to compare two percutaneous vertebral augmentation procedures in the painful osteoporotic VCF treatment. METHODS: Thirty patients were randomized to receive SJ (n = 15) or BKP (n = 15). Analgesic consumption, back pain intensity (visual analog scale (VAS)), and Oswestry Disability Index (ODI) scores were recorded preoperatively, at 5 days and 1, 3, 6, and 12 months post-surgery. Quality of life (EQ-VAS score) was evaluated at 1, 3, 6, and 12 months. Spine X-rays were taken 48 h prior to procedure and 5 days and 6 and 12 months after. RESULTS: SpineJack® led to a significantly shorter intervention period (23 vs 32 min; p < 0.001), a strong, rapid, and long-lasting decline in pain (94 vs 82 % at 12 months) and in functional disability (94 vs 90 % at 12 months), a greater and sustainable mean correction of anterior (12 ± 13 vs 0 ± 7 % for BKP, p = 0.003) and central height (12 ± 10 vs 2 ± 6 % for BKP, p = 0.001) at 12 months, and a larger restoration of the vertebral body angle still evident 12 months after implantation (-4.4° ± 5.8° vs 0.2° ± 3.0° for BKP; p = 0.012). CONCLUSIONS: This pilot study showed that both techniques were safe and efficient for the osteoporotic VCF treatment. Radiological results indicate that the SpineJack® procedure has a higher potential for vertebral body height restoration and maintenance over time.

Long-term outcome of the Cloward procedure for single-level cervical degenerative spondylosis. Clinical and radiological assessment after a 22-year mean follow-up.

PURPOSE: To evaluate the long-term outcomes of the classical Cloward procedure in single-level cervical spondylosis. METHODS: A retrospective study of 28 patients who were affected by cervical degenerative spondylosis at C4-C7 segments and treated by the Cloward technique at a single level from 1985-1995 was conducted. The average follow-up period was 22 years (range, 17-27 years). Preoperative clinical complaints were recorded and compared to the current clinical status. Preoperative, 3-6 months postoperative and a current radiographic study were analysed by evaluating the segmental and global sagittal alignment of the cervical spine as well as the occurrence of adjacent disc degeneration. RESULTS: The most frequently operated segment was C5-C6 (57.1 %), followed by C6-C7 (32.1 %) and C4-C5 (7.1 %). Pain relief and symptom recovery experienced 3-6 months following the surgery was maintained at the most recent follow-up in 85 % of patients. Adjacent disc degeneration was detected in a total of 17 cases (60.7 %). Overall, a group of 14 cases (50 %) had increased lordosis at C2-C7 at the most recent follow-up, with a mean gain of 1.5º Cobb. According to Odom's criteria, 17 patients (60.8 %) presented with excellent clinical outcome, 6 (21.4 %) presented with good outcome, 5 had a (17.8 %) fair outcome, and none had a poor outcome. CONCLUSIONS: The Cloward technique provided excellent long-term clinical outcome in the treatment of single-level cervical degenerative spondylosis. There were no major alterations of the cervical sagittal balance, and the development of adjacent segment disease (ASD) was not specifically associated with the previous surgery.