Degenerative Disc Disease

Researchers are evaluating the PerQdisc Nucleus Replacement System in patients with degenerative disc disease (DDD) affecting one or more lumbar discs. This prospective, open-label, multi-center study aims to collect additional safety and effectiveness data for this minimally invasive device. The PerQdisc is designed to replace the nucleus pulposus in lumbar discs between L1 and S1, offering an alternative to spinal fusion surgery by aiming to preserve disc height and maintain spinal motion to reduce chronic low back pain. The study involves surgical implantation of the PerQdisc device using standard anterior, lateral, or minimally invasive posterolateral approaches. All patients who meet inclusion criteria and have no exclusions will be considered for nucleus replacement surgery following review by a Medical Advisory Board. The device replaces the disc nucleus at a single level of the lumbar spine, intending to preserve spinal movement and reduce pain. Participants will be monitored for safety and performance outcomes over time, including pain and disability scores at 6 and 12 months. Researchers will assess device expulsion, failure, revision surgeries, disc height, range of motion, neurological status, analgesic use, and serious adverse events up to 5 years after surgery. The study includes clinical evaluations, imaging, and questionnaires to track progress and safety, with total follow-up extending to 5 years post-implantation.

Researchers are conducting the 100-Year Human Aging Study, an observational trial designed to follow participants over their lifespans to investigate which health measurements can predict mortality, serious diseases, and functional disability. The study aims to validate many longevity measures that currently lack prospective evidence by tracking physiological, cognitive, social, and environmental factors that change with aging. This research will generate important data to improve understanding of aging and longevity medicine. Participants undergo comprehensive multi-system clinical screenings including tests like cardiopulmonary exercise testing, body composition assessment by DEXA, echocardiography, electrocardiography, spirometry, neurocognitive testing, sensory assessments, metabolic testing, and detailed medical and social histories. The study allows for different levels of participation, from single tests to full two-visit screening batteries, and encourages repeat testing to capture health changes over time. During the study, participants receive individualized reports including investigational estimates of biological age and predicted cause of death. Researchers collect data on mortality, serious health events, chronic diseases, functional ability, and lifestyle changes through periodic follow-up over many years, potentially up to 100 years. This extensive data collection helps evaluate how well these measurements predict aging outcomes. All data are stored in raw form for future analysis and participants are supported with ongoing contact and opportunities for repeat assessments.

Researchers are evaluating a combined lifestyle intervention integrated into standard care for patients with persistent low back pain (LBP) who are overweight or obese and referred back to primary care from the hospital. The study aims to improve physical functioning and physical activity over 36 months, while also reducing healthcare and societal costs. Lifestyle factors like physical inactivity, stress, sleep quality, excess weight, and diet are addressed because they contribute to LBP and related health risks such as diabetes and cardiovascular disease. The intervention is delivered by certified physio/exercise therapists following Dutch clinical guidelines. It includes a two-year program where the first six months focus on behavioral change, and the next 18 months focus on maintaining new healthy habits. The program uses group and individual sessions with techniques such as motivational interviewing and self-monitoring. Patients set their own goals and treatment is tailored to their lifestyle risks and LBP clinical factors. The comparison group receives usual care as prescribed by medical specialists, which may include education, exercise therapy, pain medication, or referral back to primary care. Participants will attend scheduled assessments at baseline and multiple follow-up points over 36 months. Researchers will measure physical activity using a device that tracks daily steps and assess physical functioning with a disability questionnaire. Additional evaluations include pain intensity, weight, sleep quality, diet, inflammation markers, quality of life, healthcare costs, and overall perceived effect. These measurements will help determine the effectiveness and cost-effectiveness of the combined lifestyle intervention compared to usual care in this patient group.

Researchers are evaluating a new way of providing physical therapy directly in the emergency department (ED) for adults with low back pain. This multi-site feasibility trial compares this embedded ED physical therapy model to usual care at two hospital EDs within the Northwestern Medicine and University of Utah Health systems. The study aims to test if this approach can be successfully implemented, including enrolling patients and collecting long-term outcome data, as a step toward a larger future trial focused on pain and opioid use outcomes. The trial randomly assigns two hospital EDs to either have a physical therapist available on-site to start timely care for low back pain patients or to continue with usual care, which may include imaging, education, and medications but no ED physical therapist involvement. The intervention period lasts 9 months, followed by 12 months of collecting patient-reported outcomes and electronic health record data. A third hospital ED will contribute baseline data without participating in the intervention or enrollment. Participants are adult patients visiting the ED with low back pain lasting up to 30 days during daytime hours. They will complete surveys over 12 months to measure pain interference and other health outcomes. Researchers will also review health records and survey clinicians to assess how well the intervention is adopted and delivered. The study monitors participant retention and data completeness to inform future research. Overall participation lasts 21 months, including intervention and follow-up phases.

Low back pain is a leading cause of disability worldwide and a common reason for primary care visits. This research aims to improve how low back pain is managed in primary care by testing a multilevel intervention developed with general practitioners, physiotherapists, and occupational therapists. The study evaluates the effectiveness of this new care approach compared to usual care, focusing on cost-effectiveness, imaging rates, and patient disability over time. The intervention includes training general practitioners, sending reminders, providing patient education, and using a clinical pathway based on risk of chronicity. Patients may receive education and self-management support, individual physiotherapy sessions after a specialized two-day workshop, and multidisciplinary group management if needed. Care pathways involve screening, follow-up questionnaires assessing risk and work ability, and tailored treatment steps over several weeks, with coordination among healthcare providers encouraged. Participants will be monitored for 12 months through questionnaires at multiple time points and administrative data. Outcomes measured include back-related disability, imaging referrals, opioid and sick leave prescriptions, pain intensity, quality of life, work participation, and beliefs about back pain. Healthcare professionals' confidence and beliefs will also be assessed. Implementation outcomes such as acceptability and feasibility will be explored via interviews and focus groups with patients and practitioners to understand integration into routine care.

Childhood obesity is a growing public health issue worldwide and especially in Spain, where it is more prevalent in southern regions. Factors contributing to this include dietary habits, physical inactivity, socioeconomic status, and family environment. The study aims to evaluate the impact of a nutritional intervention administered by school nurses to address childhood obesity and its health consequences, including heart and musculoskeletal issues. The study compares two groups of schoolchildren aged 6 to 16. One group receives a technological intervention using podcasts, gamification, and virtual reality to promote nutrition education and healthy behaviors. The control group receives traditional brochures with nutritional information. Both groups are monitored through various measurements and biometric data collected over a 15-month period. Participants will be assessed regularly for weight, height, body composition, circumference measures, blood pressure, and adherence to the Mediterranean diet using questionnaires. Additional evaluations include a 3D avatar system for anthropometric measures. The study includes data collection at multiple timepoints from 12 weeks up to 15 months, with ongoing monitoring to assess the effectiveness of the intervention and potential health improvements.

The trial investigates the real-world use of INFUSE174 Bone Graft for patients in Korea who require lumbar fusion surgery due to degenerative disc disease. It is a prospective, observational, multi-center post-market surveillance study designed to collect data on the safety and effectiveness of this commercially available device used as intended. The study aims to follow over 600 cases during a four-year period after approval in Korea. Participants in this study are patients treated with INFUSE174 Bone Graft via anterior (ALIF) or oblique (OLIF) lumbar interbody fusion techniques. The device is approved for use as a substitute for autogenous bone graft in patients with degenerative disc disease who have undergone at least six months of nonoperative treatment. The study observes patients who have received this device according to standard care without altering their treatment. During the study, patients will be monitored for at least 12 months after surgery. Researchers will collect information about any adverse device effects and assess fusion status within this period. Clinical outcomes such as disability index (ODI), pain levels (VAS), and neurological success will be recorded at multiple timepoints including 6 weeks, 3 months, 6 months, and 12 months after surgery. This comprehensive follow-up aims to provide important real-world data on patient recovery and device performance.

Researchers are evaluating the safety and preliminary effects of a single intradiscal injection of BRTX-100 in adults with chronic lumbar disc disease, a condition causing back and leg pain due to degeneration of spinal discs confirmed by imaging and clinical evaluation. This is a phase 2, double-blind, randomized study with controlled and blinded assessments to compare BRTX-100 against a sham procedure treatment. Participants will be randomly assigned to receive either BRTX-100, which contains specially cultured stem cells from their own bone marrow combined with platelet lysate, or a control group receiving a sham procedure with saline. Those in the treatment group will undergo bone marrow collection to prepare the BRTX-100 injection, while the control group will have bone marrow and blood collected but will not receive the active injection. The study includes a Safety Run-In phase with close monitoring of the first four treated participants before continuing the randomized phase. Follow-up visits will occur at weeks 2, 12, 26, 52, and 104 or early termination. During the study, participants will be monitored through physical exams, lab tests, and safety assessments to track any adverse effects and evaluate treatment impact. Primary safety measures will be assessed from baseline through week 104, and efficacy will be evaluated through week 52. The study aims to gather detailed information on safety and initial effectiveness while participants continue regular evaluations over two years, with careful oversight by medical monitors and a data safety board.

Researchers are evaluating post-operative management approaches after a modified Lapidus arthrodesis surgery for hallux valgus, with or without additional surgeries such as Akin or Weil/Hohmann procedures. The study aims to compare the effectiveness and safety of immediate full weight-bearing versus partial weight-bearing (10-15 kg) during rehabilitation. This randomized controlled trial explores a new rehabilitation method following foot surgery to improve recovery. Participants will be randomly assigned to one of two groups after surgery: one group will follow partial weight-bearing with a specialized VACOPASO shoe and use crutches along with antithrombotic medication for 6 weeks, while the other group will have immediate complete weight-bearing with the same shoe and medication for the same period. The surgical operation follows standard clinical practices for hallux valgus correction. During the study, healing progress will be monitored through standard X-rays at 6, 12, and 24 weeks to check bone healing, hardware fixation, and fracture alignment. Pain will be measured using a Visual Analogue Scale at the day of surgery and at follow-up visits. Quality of life and functional recovery will be assessed through established foot and ankle scoring systems at multiple time points. The main outcome is the subjective functional recovery measured by the Olerud and Molander Ankle Score at 6 weeks post-surgery.

Researchers are evaluating the safety and effectiveness of a treatment called Intradiscal Cell Therapy (IDCT) for adults with mild to moderate, symptomatic lumbar degenerative disc disease affecting a single disc level between L3 and S1. This Phase III study compares IDCT to a sham procedure in a randomized, double-blinded, controlled trial involving about 162 participants. The study includes a 52-week primary period followed by another 52-week follow-up, totaling 104 weeks. Participants will be randomly assigned in a 2:1 ratio to receive either a single injection of IDCT containing 9 million cells per mL into the target disc or a sham needle insertion without active treatment. The injection is given as a 1 mL dose directly into the affected disc. Screening includes MRI and X-ray imaging to confirm eligibility and the location of disc degeneration. Randomization occurs 7 to 14 days before treatment. Throughout the study, participants will undergo assessments including pain measurement using the Visual Analogue Scale and disability evaluation with the Oswestry Disability Index at multiple time points up to two years. Researchers will also monitor adverse events and other health outcomes, including quality of life, disc volume changes, medication use, and treatment failure rates. The study involves informed consent, regular visits, and imaging to ensure safety and collect data.