Spinal Stabilization Technologies has announced the start of the LOPAIN2 clinical trial of its PerQdisc nucleus replacement device in patients with degenerative disc disease (DDD) of the lumbar spine. The PerQdisc is used for surgical replacement of a single nucleus pulposus between spinal lumbar discs L1-S1 using an anterior or lateral transpsoas approach.
Currently, there is no good surgical option for these patients, says the company, adding that the PerQdisc NRD aims to treat discogenic low back pain while maintaining disc height and preserving range of motion.
This trial is enrolling 72 patients and taking place in seven research centres across South America. Data from the LOPAIN2 trials will be used to file for the European CE mark under the Medical Device Regulation (MDR) in Europe.
Mark Novotny, CEO of Spinal Stabilization Technologies, said: “We’re impressed with the quality of clinical trial research in the South American region. These are advanced research centres with fully staffed research teams. The patient care and follow-up are excellent. In an earlier trial, no patient was lost to follow-up. The surgeons and their research staff we are working with are all highly trained in clinical research and motivated to make our trials in South America a success.”
Javier Duarte, of Hospital Americano (Asuncion Paraguay), and principal investigator of the study, added: “The results I’m getting with the PerQdisc are excellent. I have been able to refine the technique to a point where I’m comfortable routinely offering the option to my DDD patients.”
Fellow principal investigator, Rodolfo Paez, of Hospital de San José (Bogota, Colombia), commented: “I believe nucleus replacement is finally here to stay. I enrolled and treated the first patient in LOPAIN2. The procedure is easy to learn, and the result is a custom implant that is fitted perfectly to the patient’s anatomy.”
