TAMPA, Fla., March 20, 2024 /PRNewswire/ — Final data from a landmark study on PainTEQ’s posterior approach SI joint fusion with the LinQ™ implant revealed improved pain and function scores and an excellent safety profile at 12 months post-operation.
The Single Arm, Multicenter, Prospective, Clinical Study on a Minimally Invasive Posterior Sacroiliac Fusion Allograft Implant (SECURE) study represents the largest and first-of-its-kind clinical trial for any posterior approach, and addresses the paucity of data for 12-month prospective outcomes. The study’s data on 83 patients revealed a statistically significant mean improvement in VAS scores (0-100) of 43.3 at 12 months versus baseline. There was also a strong safety profile with only five total adverse events and no implant-related significant adverse events were observed.
“The demonstrated effectiveness and safety profile of this treatment establishes it as a clear next choice for patients not responding to conservative care,” said Aaron Calodney, M.D., Director of Clinical Research at Precision Spine Care in Tyler, TX, who served as the study’s lead author.
In addition to the significant improvement in VAS scores, SECURE also showed statistically significant improvements in ODI scores, a measure of a patient’s perceived disability due to pain. Finally, the study found significant improvement in all PROMIS-29 domains, which represent pain intensity, sleep disturbance, fatigue, anxiety, depression, ability to participate in social roles and activities, and physical function.
SECURE marks the 8th publication directly related to the study of the LinQ implant itself, emphasizing PainTEQ’s ongoing commitment to clinical excellence through evidence generation.
“We are very encouraged by the results from the SECURE study,” said Sean LaNeve, PainTEQ’s CEO. “The 12-month data proves what our physicians and patients are experiencing and sharing with us on a consistent basis. The principles of medicine are to always exhaust the safest, least-invasive options first, and we believe SECURE proves that LinQ is a valid and valuable option for patients and physicians to consider before advancing to more invasive SI joint fusion devices.”
About PainTEQ: PainTEQ was built to bring interventional procedures to the market. Working with pain management specialists to help reduce and eliminate SI joint dysfunction, PainTEQ’s LinQ implant and single-use instruments aim to immediately provide clinical benefits to individuals living with incapacitating lower back pain through a minimally invasive outpatient procedure. Learn more at www.painteq.com.
About LinQ: The LinQ SI Joint Stabilization System provides patients with a minimally invasive option to combat pain due to sacroiliac disease. After a thorough diagnostic process, physicians may help alleviate – and in many cases eliminate – chronic pain by placing a single LinQ allograft into the SI joint. With its large graft window, the LinQ implant is designed to create an ideal environment for long-term fusion.
SOURCE PainTEQ