Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases

Launched by SPINESAVE AG · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring different types of rods used in spinal surgery to treat issues related to the lower back, such as degenerative spinal stenosis and other conditions that cause back pain. The study aims to determine if using high- or mid-flex rods is just as effective and safe as using low-flex rods in reducing back pain and improving function after surgery.

To participate in this trial, candidates should be adults aged 36 to 75 with specific degenerative symptoms in their lower spine. They must also be able to attend follow-up visits and have a body mass index (BMI) under 32. Participants will undergo surgery and will be monitored afterward to see how well they recover and how much their pain decreases. This trial is currently recruiting, and it's important to note that certain conditions, such as severe bone issues or active infections, may exclude individuals from participating. If you or a loved one are dealing with chronic back pain, this study could be a potential option to consider for treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • degenerative symptoms in 1 to 2 segments in the lumbar spine L1-S1
• • signed informed consent of participant
• • confirmation of the participant that the attendance of follow-up visits are intended
• • Body-Mass-Index \< 32
• • Pedicle screw axis distance \< 30mm
• * one or more of the following indications:
• • (dynamic) stenosis in the spinal canal
• • neuroforaminal stenosis
• • facet joint syndrome / spondylarthrosis
• • discopathy (recurrent disc hernia)
• • degenerative spondylolisthesis (Meyerding \<1)
• • instability (hypermobility with antelishtesis, hypomobility with retrolisthesis if decompressed)
• Exclusion Criteria:
• • missing bone structure, e.g. due to congenital anomalies or sever anatomical deformities that make anchoring of the implant impossible
• • damaged structural tissue, e.g. due to a bone fracture
• • application to the thoracic or cervical spine
• • pronounced idiopathic scoliosis
• • spondylolisthesis \> Meyerding grad 1
• • isthmic spondolylysis
• • bone tumor
• • osteochondrosis modic type I, II or III
• • osteoporosis, which could impair screw anchoring
• • history with third party implants
• • patients with an active local or systemic infection
• • known allergy to titatnium alloys
• • skeleton in growth (epiphyseal joints not closed)
• • severe muscular neuronal or vascular disease
• • immunosuppresive therapy
• • long-term therapy with cortisone
• • heavy smokers (regular consumption of more than six cigarettes per day), drug addicts and alcoholics
• • chronic pain patients
• • incapable of judgment or emergency situation
• • implantation during pregnancy