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SITU-NDORMS has announced the launch of three major new clinical trials. Funded by the NIHR, these studies are providing evidence for the treatment of chronic low back pain, knee osteoarthritis, and ACL injuries.

A spinal column and knee

The first trial, FORENSIC, is investigating the role and effectiveness of lumbar fusion surgery. The procedure, which fuses vertebrae to alleviate chronic low back has been declining in the UK due to uncertainty over its effectiveness, especially compared to conservative care. This study, FusiOn veRsus bEst coNServatIve Care (FORENSIC-UK) will look to recruit 270 patients from October 2024, to provide evidence that spinal fusion may still be a beneficial option in appropriate patients.

The second trial, GEKO, is evaluating a novel minimally invasive treatment for knee osteoarthritis. By blocking abnormal blood vessels around the joint, the researchers hope to relieve pain and improve function in patients who are in a 'treatment gap' between simple care through lifestyle changes, physiotherapy and exercise, but are not yet candidates for surgical full knee replacement.

The Genicular Artery Embolisation for the symptomatic treatment of knee osteoarthritis refractory to conservative management (GEKO) trial plans to recruit 216 participants from at least 12 sites, starting in January 2025.

Thirdly, the ACL STARR trial is seeking to explore the optimal surgical treatment for tears in the anterior cruciate ligament (ACL), one of the key ligaments in the knee. Surgery has been shown to provide better functional outcomes than non-operative approaches, but ACL STARR will compare whether a newer direct repair approach is superior to traditional ACL reconstruction using a graft. Recruiting over 280 patients to determine the superior technique, the trial is looking to open in January 2025.

FORENSIC and ACL STARR are funded under the NIHR Health Technology Assessment (HTA) Programme, and are combined bids with the Australian NHMRC. Mirrored independent studies in the UK and Australia will answer research questions important to both countries and populations.

GEKO is funded under the NIHR Efficacy and Mechanism Evaluation (EME) Programme.