Cervical Degenerative Disc Disease

Researchers are evaluating the safety and effectiveness of the PerQdisc Nucleus Replacement Device NRD for patients with degenerative disc disease DDD causing chronic low back pain. This prospective, open-label, multi-center study involves 72 patients who have DDD in one or more lumbar discs between L1 and S1. The study aims to collect additional data on this minimally invasive device, which is designed to maintain disc height and preserve spinal motion compared to the current standard spinal fusion surgery. Participants will undergo nucleus replacement surgery using the PerQdisc device via standard anterior, lateral, or minimally invasive posterolateral surgical approaches to replace the single nucleus pulposus in the affected lumbar disc. All surgeries require approval from a Medical Advisory Board. The study focuses on patients who have exhausted at least six months of conservative treatments for their back pain and meet specific criteria, including disc height and pain scores. During the study, participants will be monitored closely with evaluations at multiple time points up to five years. Researchers will assess performance outcomes such as disability Oswestry Disability Index, pain levels Visual Analog Scale, disc height, and range of motion, as well as safety outcomes including device expulsion, failure, neurological status, revision surgeries, and serious adverse events. Follow-up visits will include questionnaires, imaging, and clinical assessments to track the devices impact over time.

Researchers are evaluating the use of high-resolution 7 Tesla MRI imaging of the spine to better distinguish bone spurs from disc material and to more clearly show compressed nerves in the neuroforamen compared to standard 3 Tesla MRI. This study aims to provide surgeons with detailed anatomical images before surgery, potentially reducing the need for CT scans when bone anatomy is crucial. Participants undergo a 7 Tesla MRI scan of the spine, which is a diagnostic imaging procedure. The study compares the 7 Tesla MRIs ability to differentiate compressed nerves with that of the 3 Tesla MRI over a two-year period. This observational study does not involve treatment but focuses on imaging evaluation. During the study, participants will have MRI scans and may provide informed consent for participation. Researchers will assess imaging details to measure how well the 7 Tesla MRI depicts nerve compression compared to standard imaging. The primary outcome is the differentiation of compressed nerves in the neuroforamen over two years. Participants involvement length and visit frequency depend on the imaging schedule and clinical needs.

Degenerative Cervical Myelopathy DCM is an age-related condition mainly affecting people aged 50 and over, caused by changes in the spine like ligament ossification or disc problems that compress the cervical spinal cord. It leads to symptoms such as hand numbness, clumsiness, and difficulty walking. This research aims to develop new surgical criteria based on physical performance tests alongside MRI and clinical signs to better guide surgery decisions for DCM, focusing on the Chinese population. The study involves confirming DCM diagnosis using MRI and orthopedic surgeon evaluation. Researchers will use physical performance tests such as the 10-second Grip and Release test, 10-second Stepping Test, and Foot Tapping Test over 24 months to assess functional deficits. These tests, combined with clinical indicators and MRI findings, will help establish objective criteria to predict the need for surgery. Participants will be evaluated regularly for their physical abilities and neurological function using these performance tests. The study will monitor changes over 24 months to assess hand and gait coordination. Researchers will also use clinical signs and patient cognitive ability to understand symptom progression. The goal is to improve surgical decision-making and recovery outcomes by identifying clear physical performance benchmarks in DCM patients.

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 post-operative management approaches after a modified Lapidus arthrodesis surgery for hallux valgus, with or without additional surgeries such as Akin or WeilHohmann 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.

This trial investigates the safety and effectiveness of Intradiscal Cell Therapy IDCT compared to a Sham procedure for adults aged 18 to 75 with mild to moderate symptomatic degenerative disc disease at a single lumbar level L3-S1. The study is a Phase III, randomized, double-blinded, sham-controlled, multicenter trial involving 162 participants. The target disc is identified by imaging and must meet specific grading criteria, with participants experiencing chronic low back pain unresponsive to conservative treatments. Participants will be randomly assigned in a 21 ratio to receive either a single intradiscal injection of 9 million cells in 1 mL IDCT or a Sham needle insertion up to the annulus of the target disc. The target disc is one of L3L4, L4L5, or L5S1. Randomization occurs 7 to 14 days before treatment. The study includes a 52-week primary evaluation period followed by an additional 52-week follow-up, totaling 104 weeks for monitoring. Throughout the study, participants will undergo baseline and follow-up assessments including MRI and X-ray imaging, Visual Analogue Scale VAS for low back pain, Oswestry Disability Index ODI, and other health and disability questionnaires. Adverse events and treatment safety will be tracked from Day 1 through Week 104. Researchers will also measure disc volume, pain medication use, and treatment failure rates while participants adhere to study protocols and visit schedules over two years.

This research aims to observe and compare the outcomes of patients undergoing anterior cervical discectomy and fusion ACDF for degenerative disc disease. The study looks at two types of procedures one using a device called Tritanium C and the other using structural allograft bone with plates. It is a combined observational study including both retrospective and prospective data collection to evaluate fusion success and adverse events. The study involves two groups a retrospective cohort of up to 40 patients who previously received ACDF with structural allograft bone and plates, and a prospective group of 20 patients receiving Tritanium C as part of their standard care. Data includes patients treated at one or two contiguous cervical spine levels. The retrospective group will be matched to the prospective patients in a 21 ratio. Both cohorts have follow-up visits and imaging at baseline, 6 months, and 12 months post-operation to assess fusion and other outcomes. Participants will have clinical assessments including neck disability, neck and arm pain, and neurological status at baseline and during follow-up visits at 3, 6, and 12 months post-operation. Researchers will collect imaging and questionnaire data to measure fusion success and adverse events over time. The total participation period for retrospective patients includes up to one year of follow-up, while prospective patients are monitored through their standard care schedule. The study is conducted without blinding or randomization.

Researchers are evaluating a new way to provide preoperative information to patients who are candidates for spinal or urological surgery. This study is an interventional, randomized controlled trial conducted at multiple centers. It aims to compare a new multimedia-based method that objectively checks patient understanding against the standard informed consent process to see which better supports patient decision-making about surgery. Participants in the experimental group will receive detailed information through videos with surgical options, graphics, and animations. They will also have interviews with the surgeon and caregivers using 3D-printed models to guide shared decision-making. After deciding on surgery, patients will join educational programs to reinforce understanding before a final surgeon interview and signing of informed consent. The control group will receive the usual care, including a standard explanatory interview and consent signing. Throughout the study, participants will complete questionnaires assessing satisfaction, comprehension, mental health, pain, disability, urinary and sexual function, and legal outcomes at multiple time points before surgery, at discharge, and at two and six months after surgery. The research team will monitor these measures to evaluate the impact of the new method on patient understanding and decision satisfaction over time.

This research aims to compare two manual therapy techniques, Active Release Technique and Strain-Counterstrain, in adults aged 18 to 45 years who experience non-specific neck pain. The study focuses on how these treatments affect pain levels, neck range of motion, the cranio-vertebral angle, and disability. Neck pain is a common problem worldwide and in Pakistan, often caused by muscle strain or poor posture, leading to discomfort and reduced quality of life. This trial seeks to provide insights into which technique may better improve symptoms and function in affected individuals. Participants will be randomly assigned to one of two groups. Group A will receive the Active Release Technique applied to the trapezius, levator scapulae, sternocleidomastoid, and suboccipital muscles for 15 minutes. Group B will receive the Strain-Counterstrain technique on the same muscles and for the same duration. Both groups will also receive hot packs, stretching of superficial neck muscles, and neck isometric exercises. Treatments will be given over four weeks, with assessments at the start and end of this period. During the study, participants will be evaluated for pain using the Numeric Pain Rating Scale, neck disability with the Neck Disability Index, neck posture by measuring the cranio-vertebral angle, and neck mobility with a goniometer. These measurements will be recorded at the beginning and after four weeks of treatment. The study will be conducted at Safi Teaching Hospital in Faisalabad, Pakistan, with ethical approval and informed consent. The findings aim to help improve clinical care for people with non-specific neck pain by identifying more effective manual therapy options.

This research aims to compare the immediate effects of single-session motor imagery exercises and motor control exercises on individuals who have chronic neck pain lasting at least 12 weeks. The study focuses on measuring changes in pain severity, pressure pain threshold, cervical proprioception, and motor imagery ability. Participants must have a pain severity score of at least 3 cm on the visual analog scale and meet cognitive screening criteria. Participants will be randomly assigned to one of two groups to receive either a single session of motor imagery exercise following the PETTLEP model or a single session of motor control exercise. Both interventions are designed to evaluate how these therapies affect pain and neck function in a controlled setting. The study is double-blinded and aims to assess outcomes immediately before and after the intervention session. During the study, participants will be assessed at baseline and immediately after the intervention for pain severity, pressure pain threshold, cervical proprioception, and motor imagery. These measures will help researchers understand the acute impact of each exercise type on neck pain and related functions. The entire participation involves one session of treatment and immediate evaluation of responses to the exercise.