Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants: 24-Month Follow-Up.

BACKGROUND: Strong evidence supports minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction. OBJECTIVE: To report safety and effectiveness of SIJF using a 3D-printed TTI at 24 months. METHODS: SIJF with TTI was performed in 51 subjects. Structured follow-up occurred at 3, 6, 12 and 24 months. Both quality of life questionnaires and functional tests were performed at all study visits. RESULTS: 84% of subjects were available for 24-month follow-up. Observed were rapid and persistent improvements in dysfunction due to pain (Oswestry Disability Index [ODI], mean 52.8 at baseline and 28.3 at 24 months, p<0.0001) and SIJ pain ratings (mean 78.5 at baseline [0-100 scale] to 21.5 at 24 months). Opioid use for SIJ pain decreased markedly from baseline. Physical function tests impaired by SIJ pain showed persistent improvements compared to baseline. There was no evidence of device breakage, migration or subsidence and few late adverse events occurred attributable to the device. CONCLUSION: In this prospective study, SIJF using 3D-printed TTI resulted in immediate, marked and persistent improvements in pain and quality of life, with improved physical function, reduced opioid use and a low rate of late device-related adverse events. LEVEL OF EVIDENCE: Level II.

Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants.

BACKGROUND: Prior trials provide strong evidence supporting minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction. OBJECTIVE: To assess the safety and effectiveness of SIJF using a 3D-printed TTI. METHODS: Fifty-one subjects with carefully diagnosed SIJ dysfunction underwent SIJF with 3D TTI. Subjects completed pain, disability and quality of life questionnaires at baseline and 3, 6 and 12 months postoperatively. Functional tests were performed in the clinic at each visit. Pelvic CT scans were independently evaluated for radiolucency, bridging bone and other endpoints. RESULTS: Ninety percent had 12-month follow-up. Dysfunction due to pain (Oswestry Disability Index [ODI]) decreased from 52.8 at baseline to 27.9 at 12 months (p<.0001 for change, p=.004 for non-inferiority primary hypothesis). SIJ pain scores improved from 78 preoperatively to 21 at 12-month follow-up (P<.0001). Ninety-six percent experienced an improvement of 20 points or more in VAS SIJ pain by month 12. The percentage of subjects reporting minimal difficulty performing physical activities typically impaired by back/SIJ pain improved significantly for all activities. The proportion of subjects taking opioids for SIJ pain decreased from 57% to 22%. Three physical function tests improved markedly from baseline to 1 year. Positive radiographic findings were observed, including a 70% and 77% rate of bone bridging observed at 6 and 12 months, respectively. There was no evidence of device breakage, migration or subsidence. CONCLUSION: In this prospective multicenter trial, SIJF with 3D-printed TTI markedly improved pain, disability and quality of life. Results are consistent with 3 prior prospective multicenter trials of a milled implant but suggest accelerated bony fusion with the newer implant. Physical function improved, and high rates of opioid cessation were observed. LEVEL OF EVIDENCE: Level II.

Long-Term Prospective Clinical And Radiographic Outcomes After Minimally Invasive Lateral Transiliac Sacroiliac Joint Fusion Using Triangular Titanium Implants.

BACKGROUND: Accumulating evidence supports the long-term safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) for sacroiliac joint dysfunction. OBJECTIVE: To report 5-year clinical and radiographic follow-up in patients undergoing SIJF using triangular titanium implants (TTI). METHODS: One hundred and three subjects at 12 centers treated with SIJF using TTI in two prospective clinical trials (NCT01640353 and NCT01681004) were enrolled and followed in the current study (NCT02270203) with clinic visits at 3, 4 and 5 years. CT scans performed at 5 years were compared to prior CT scans (at 1 or 2 years) by an independent radiologist. RESULTS: Compared to baseline scores, SIJ pain scores at 5 years decreased by a mean of 54 points, disability scores (Oswestry Disability Index) decreased by 26 points, and quality of life scores (EuroQOL-5D time trade-off index) increased by 0.29 points (0-1 scale) (all p<0.0001). Satisfaction rates were high and the proportion of subjects taking opioids decreased from 77% at baseline to 41% at 5-year follow-up. Independent radiographic analysis showed a high rate (98%) of bone apposition to implants on both the sacral and iliac sides of the SI joint, with a high rate of bony bridging (87%) and a low rate of radiolucencies suggestive of loosening (5%). CONCLUSION: A 5-year follow-up showed continued excellent clinical responses in patients with SIJ pain treated with SIJF using triangular titanium implants along with a high rate (88%) of joint fusion. LEVEL OF EVIDENCE: Level II.

Minimally invasive lateral transiliac sacroiliac joint fusion using 3D-printed triangular titanium implants.

Background: Minimally invasive sacroiliac joint (SIJ) fusion (SIJF) has become an increasingly accepted surgical option for chronic SI joint dysfunction, a prevalent cause of chronic low back/buttock pain. Objective: To report clinical and functional outcomes of SIJF using 3D-printed triangular titanium implants (TTI) for patients with chronic SI joint dysfunction. Methods: A total of 28 subjects with SIJ dysfunction at 8 centers underwent SIJF with 3D TTI and had scheduled follow-up to 6 months (NCT03122899). Results: Mean preoperative SIJ pain score was 79.1 and mean preoperative Oswestry Disability Index (ODI) was 49.9. At 6 months, pain scores decreased by 51 points and ODI decreased by 23.6 points (both p<0.0001). The proportion of subjects able to perform various back/pelvis-related physical functions with minimal difficulty improved significantly for nearly all activities. Opioid use decreased and physical function, as assessed with three objective tests, improved. Conclusion: Early results from this prospective multicenter trial confirm that clinical responses to a 3D triangular titanium implant for SIJF are similar to those from prior trials, with improved physical function and decreased opioid use. Level of evidence: Level II.

Long-term prospective outcomes after minimally invasive trans-iliac sacroiliac joint fusion using triangular titanium implants.

BACKGROUND: Minimally invasive sacroiliac joint fusion (SIJF) has become an increasingly accepted surgical option for chronic sacroiliac (SI) joint dysfunction, a prevalent cause of unremitting low back/buttock pain. OBJECTIVE: The objective of this study was to report clinical and functional outcomes of SIJF using triangular titanium implants (TTI) in the treatment of chronic SI joint dysfunction due to degenerative sacroiliitis or sacroiliac joint (SIJ) disruption at 3 years postoperatively. METHODS: A total of 103 subjects with SIJ dysfunction at 12 centers were treated with TTI in two prospective clinical trials (NCT01640353 and NCT01681004) and enrolled in this long-term follow-up study (NCT02270203). Subjects were evaluated in study clinics at study start and again at 3, 4, and 5 years. RESULTS: Mean (SD) preoperative SIJ pain score was 81.5, and mean preoperative Oswestry Disability Index (ODI) was 56.3. At 3 years, mean pain SIJ pain score decreased to 26.2 (a 55-point improvement from baseline, p<0.0001). At 3 years, mean ODI was 28.2 (a 28-point improvement from baseline, p<0.0001). In all, 82% of subjects were very satisfied with the procedure at 3 years. EuroQol-5D (EQ-5D) time trade-off index improved by 0.30 points (p<0.0001). No adverse events definitely related to the study device or procedure were reported; one subject underwent revision surgery at year 3.7. SIJ pain contralateral to the originally treated side occurred in 15 subjects of whom four underwent contralateral SIJF. The proportion of subjects who were employed outside the home full- or part-time at 3 years decreased somewhat from baseline (p=0.1814), and the proportion of subjects who would have the procedure again was lower at 3 years compared to earlier time points. CONCLUSION: In long-term (3-year) follow-up, minimally invasive trans-iliac SIJF with TTI was associated with improved pain, disability, and quality of life with relatively high satisfaction rates. LEVEL OF EVIDENCE: Level II. CLINICAL RELEVANCE: SIJF with TTI.

Work intensity in sacroiliac joint fusion and lumbar microdiscectomy.

BACKGROUND: The evidence base supporting minimally invasive sacroiliac (SI) joint fusion (SIJF) surgery is increasing. The work relative value units (RVUs) associated with minimally invasive SIJF are seemingly low. To date, only one published study describes the relative work intensity associated with minimally invasive SIJF. No study has compared work intensity vs other commonly performed spine surgery procedures. METHODS: Charts of 192 patients at five sites who underwent either minimally invasive SIJF (American Medical Association [AMA] CPT® code 27279) or lumbar microdiscectomy (AMA CPT® code 63030) were reviewed. Abstracted were preoperative times associated with diagnosis and patient care, intraoperative parameters including operating room (OR) in/out times and procedure start/stop times, and postoperative care requirements. Additionally, using a visual analog scale, surgeons estimated the intensity of intraoperative care, including mental, temporal, and physical demands and effort and frustration. Work was defined as operative time multiplied by task intensity. RESULTS: Patients who underwent minimally invasive SIJF were more likely female. Mean procedure times were lower in SIJF by about 27.8 minutes (P<0.0001) and mean total OR times were lower by 27.9 minutes (P<0.0001), but there was substantial overlap across procedures. Mean preservice and post-service total labor times were longer in minimally invasive SIJF (preservice times longer by 63.5 minutes [P<0.0001] and post-service labor times longer by 20.2 minutes [P<0.0001]). The number of postoperative visits was higher in minimally invasive SIJF. Mean total service time (preoperative + OR time + postoperative) was higher in the minimally invasive SIJF group (261.5 vs 211.9 minutes, P<0.0001). Intraoperative intensity levels were higher for mental, physical, effort, and frustration domains (P<0.0001 each). After taking into account intensity, intraoperative workloads showed substantial overlap. CONCLUSION: Compared to a commonly performed lumbar spine surgical procedure, lumbar microdiscectomy, that currently has a higher work RVU, preoperative, intraoperative, and postoperative workload for minimally invasive SIJF is higher. The work RVU for minimally invasive SIJF should be adjusted upward as the relative amount of work is comparable.

Durable intermediate-to long-term outcomes after minimally invasive transiliac sacroiliac joint fusion using triangular titanium implants.

BACKGROUND: Sacroiliac joint (SIJ) fusion (SIJF), first performed 95 years ago, has become an increasingly accepted surgical option for chronic SIJ dysfunction. Few studies have reported intermediate- or long-term outcomes after SIJF. OBJECTIVE: The objective of this study is to determine patient-based outcomes after SIJF for chronic SIJ dysfunction due to degenerative sacroiliitis or SIJ disruption at ≥3 years of follow-up. METHODS: Consecutive patients who underwent SIJF prior to December 2012 were contacted over phone or through email. Participants completed questionnaires in clinic, over phone or by email, regarding SIJ pain, activities related to SIJ dysfunction, and the Oswestry Disability Index. Charts were reviewed to extract baseline parameters and the clinical course of follow-up. RESULTS: One hundred seven patients were eligible and participated in this study. Mean (standard deviation) preoperative SIJ pain score was 7.5 (1.7). At mean follow-up of 3.7 years, the mean SIJ pain score was 2.6 (representing a 4.8-point improvement from baseline, P<0.0001) and the mean Oswestry Disability Index was 28.2. The ability to perform activities commonly impaired by SIJ dysfunction showed positive improvements in most patients. SIJ revision surgery was uncommon (five patients, 4.7%). Fourteen patients (13.1%) underwent contralateral SIJF during follow-up, 25.2% of patients had additional non-SIJ-related lumbar spine or hip surgeries during follow-up. CONCLUSION: In intermediate- to long-term follow-up, minimally invasive transiliac SIJF was associated with improved pain, low disability scores, and improved ability to perform activities of daily living.

Osteocel Plus cellular allograft in anterior cervical discectomy and fusion: evaluation of clinical and radiographic outcomes from a prospective multicenter study.

STUDY DESIGN: Prospective, multicenter, nonrandomized, institutional review board-approved clinical and radiographic study. OBJECTIVE: To evaluate and summarize the 2-year outcomes of patients treated with Osteocel Plus cellular allograft as part of an anterior cervical discectomy and fusion procedure. SUMMARY OF BACKGROUND DATA: Osteocel Plus is an allograft cellular bone matrix containing native mesenchymal stem cells and osteoprogenitor cells that is intended to mimic the performance of iliac crest autograft without the morbidity associated with its harvest. METHODS: A total of 182 patients were treated with anterior cervical discectomy and fusion using Osteocel Plus in a polyetheretherketone cage and anterior plating at 1 or 2 consecutive levels. Clinical outcomes included visual analogue scale for neck and arm pain, neck disability index, and SF-12 physical and mental component scores. Computed tomography and plain film radiographic measures included assessment of bridging bone, disc height, disc angle, and segmental range of motion. RESULTS: A total of 249 levels were treated in 182 patients. Mean procedure time was 100 minutes, blood loss was less than 50 mL in 93% of patients, and hospital stay was 1 day or less in 84% of patients. Significant (P<0.05) average improvements in clinical outcomes from preoperatively to 24 months included the following: neck disability index: 21.5%; visual analogue scale neck: 34 mm; visual analogue scale arm: 35 mm; SF-12 physical component score: 11.2; SF-12 mental component score: 6.8. At 24 months, 93% of patients were satisfied with their outcome. In patients treated at a single level with a minimum of 24-month follow-up, 92% (79/86) of levels achieved solid bridging and 95% of levels demonstrated range of motion of less than 3°. In combined single- and 2-level procedures, 87% (157/180) of levels achieved solid bridging and 92% (148/161) had range of motion of less than 3° at 24 months. No patient required revision for pseudarthrosis. CONCLUSION: Improvements in clinical results at 2 years, high patient satisfaction, and high radiographic and clinical fusion rates provide confidence in Osteocel Plus as an effective alternative to structural allograft or autograft in anterior cervical discectomy and fusion procedures. LEVEL OF EVIDENCE: 4.

Quadriparesis and spinal cord stimulation: case report.

STUDY DESIGN: Case report. OBJECTIVE: To report the occurrence of a rare complication following revision of a spinal cord stimulator. SUMMARY OF BACKGROUND DATA: Puncture of the dura with placement of an electrode within the spinal cord has not been reported as a complication of spinal cord stimulation. METHODS: A patient presented with upper and lower extremity weakness following inadvertent placement of an electrode into the spinal cord. The clinical case is presented as well as review of the literature. RESULTS: The patient had the electrode successfully removed; however, her neurologic status deteriorated. CONCLUSION: Revision of spinal cord stimulators is usually a safe procedure. However, placement of an electrode within the spinal cord during the revision process is a potential complication resulting in severe neurologic injury.