Clinical Research Directory

A Study of LDGraft In Single Level Lumbar Interbody Fusion

The objective of the study is to evaluate the safety and effectiveness of LDGraft (investigational device) when applied in a lumbar interbody fusion procedure in the treatment of patients with lumbar Degenerative Disc Disease (DDD).

PMCF Study Fortilink-TC Ti

This study is setup to be able to gather information on the safety and performance of the Fortilink-TC Ti cage of Paradigm Spine GmbH, up to one year after the surgery. The device is intended to be used in intervertebral fusion surgery. Around 50 participants will participate in this study in 2 hospitals. The Fortilink-TC Ti cage is meant to be placed in the lower back, to treat degenerative disc disease with up to grade I spondylolisthesis. The study will involve data gathering based on routine care. The study will only entail collection of data (medical history prior to the surgery, data from the surgery and data in the follow up after one year). Fortilink-TC Ti cages are not new, but have been on the market since 2020. The clinical study is performed to actively gather data on the use of this product in the intended group of patients, to monitor its safety and performance. The treatment and follow-up provided in this study does not differ from the standard of care; meaning that participants in the study will receive the same treatment and follow the same follow-up visits and assessments as patients undergoing the same procedure outside of the study.

PMCF Study Fortilink-TS Ti

This study is setup to be able to gather information on the safety and performance of the Fortilink-TS Ti cage of Paradigm Spine GmbH, up to one-year after the surgery. The device is intended to be used in intervertebral fusion surgery. Around 50 participants will participate in this study in 2 hospitals. The Fortilink-TS Ti cage is meant to be placed in the lower back, to treat degenerative disc disease with up to grade I spondylolisthesis. The study will involve data gathering based on routine care. The study will only entail collection of data (medical history prior to the surgery, data from the surgery and data in the follow up after one year). Fortilink-TS Ti cages are not new, but have been on the market since 2020. The clinical study is performed to actively gather data on the use of this product in the intended group of patients, to monitor its safety and performance. The treatment and follow-up provided in this study does not differ from the standard of care; meaning that participants in the study will receive the same treatment and follow the same follow-up visits and assessments as patients undergoing the same procedure outside of the study.

A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages in the Lumbar Spine

The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo interbody spinal fusion using the EVOS Lumbar Interbody System.

Fusion or Not - a Study on Low Back Pain

Problems from the musculoskeletal system are one of the most common reasons for disability and sick leave. These problems include low back pain. Low back pain affects as many as 8 out of 10 individuals at some point in life. In most people it is quickly transient with little, or only short-term, impact on function and quality of life. In some individuals, the problems can become long-lasting and significantly impair the quality of life. When analgesic and physiotherapeutic treatment have been tried and the problems are still not manageable, and have lasted more than a year, surgical treatment consisting of fusion surgery of the painful part of the spine may come in question. In Sweden, approximately 600 fusion surgeries are performed annually for low back pain. There are a few randomized studies comparing fusion surgery for low back pain with non-surgical treatments, but these have showed different results. The effect of fusion surgery on low back pain is therefore uncertain. Surgical treatments brings with it a clear placebo effect. Other studies on pain in other parts of musculoskeletal system than the back has not been able to show that a surgical treatment is always better than placebo surgery. This has called into question the effect of surgery on many painful conditions of the musculoskeletal system. No placebo-controlled surgical studies have been done on fusion surgery for low back pain. A placebo surgical controlled study is the only way to ascertain whether fusion surgery is the right treatment for low back pain. In this study, 90 individuals will undergo surgical treatment for low back pain. After surgical exposure, the surgeon will be informed whether fusion surgery should be performed or not. Half of the patients will undergo a fusion procedure with implants and the other half will not undergo the fusion procedure and will not receive implants. Treatment randomization will be performed during surgery, and the individuals undergoing treatment and the staff taking care of the individual after surgery will be blinded for treatment allocation during 6 months. That means that the individuals participating in the study and the staff who meet the individuals after surgery won't know if the individual had fusion surgery or no fusion surgery until after the 6 month follow-up. The most important outcome of the study is the result of a questionnaire-based measure of back function answered by the participating individuals.

Biologic Injection For Adults With Lumbar Disc Herniation

The goal of this clinical trial is to find out whether adding a bone-marrow aspirate concentrate (BMAC) injection during surgery can improve recovery in adults undergoing lumbar microdiscectomy for a lumbar disc herniation. The main questions it aims to answer are: * Does the BMAC injection lead to better disc tissue health after surgery (as seen on MRI scans)? * Does the BMAC injection lead to greater improvement in pain and disability compared to surgery alone? Participants will be adults aged 18 and older who are scheduled for lumbar microdiscectomy surgery. Researchers will compare one group of participants receiving the standard-of-care surgery plus the BMAC injection with another group receiving the same surgery without the injection to see if the injection offers added benefit. Participants will: * Have surgery (microdiscectomy) with or without the injection. * Complete pain and disability questionnaires at several times over 2 years. * Undergo MRI scans at baseline and follow-up to assess disc structure and tissue health. * Provide samples of leftover disc or bone-marrow tissue (as applicable) from surgery for analysis.