Peripheral Neuropathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 22 to 75 years at the time of enrollment.
• People diagnosed with nerve or spinal cord problems in the neck (cervical spine), causing pain, tingling, or weakness along a specific nerve pathway from levels C3 to C7.
• People experiencing at least one of the following: neck or arm pain rated at least 3 out of 10; reduced muscle strength; abnormal sensation such as increased or decreased feeling; or abnormal reflexes.
• People whose symptoms come from one or two neighbouring levels of the neck spine, between C3 and C7.
• People whose scans (X-ray, CT, or MRI) show a physical problem at the affected level, such as reduced disc height, spinal degeneration, or a herniated disc, matching their symptoms.
• People with a Neck Disability Index score of at least 30 out of 100 (a standard measure of how neck problems affect daily life — confirm with trial site).
• People who have not responded to non-surgical treatments (such as rest, heat, physiotherapy, chiropractic care, massage, or pain medication) for around six weeks, or whose symptoms are getting worse despite continuing non-surgical treatment.
• People who have not had previous surgery at the affected neck levels and have no further planned surgery at those or neighbouring levels.
• People for whom surgery through the front of the neck is considered appropriate by their treating doctor.
• People whose bones have finished growing by the time of surgery.
• People who have been medically cleared for surgery by their doctor.
• Women of childbearing age who are not pregnant, not breastfeeding, and who agree not to become pregnant during the study period.
• People who are willing and able to follow the study plan as required.
• People who have signed a written informed consent form.
• People who are willing to stop taking anti-inflammatory medications (NSAIDs), such as ibuprofen, from one week before surgery until three months after surgery.

Who may not be able to join:

• People with a cervical spine condition other than degenerative disc disease that requires surgery at the affected levels.
• People whose neck shows instability between segments, based on movement X-rays showing certain specific measurements beyond accepted thresholds (confirm with trial site).
• People who need surgery at more than two levels of the cervical spine.
• People who have a completely stiff or naturally fused spinal level next to the levels being treated.
• People with severe damage to the small joints at the back of the affected neck vertebrae.
• People who have previously had surgery at the affected neck levels or at neighbouring levels.
• People with a history of significant injury to the C3–C7 area of the neck involving bones or ligaments.
• People previously diagnosed with osteomalacia (a condition causing softening of the bones).
• People with certain risk factors for osteoporosis — including postmenopausal non-Black women over 60 weighing less than 140 pounds, postmenopausal women with a history of a non-injury-related hip, spine, or wrist fracture, men over 60 with a non-injury-related hip or spine fracture, people taking bisphosphonate medications for osteoporosis, or people who have used high-dose steroids long-term — if a bone density scan (DEXA) shows a T-score of -2.5 or lower.
• People with an active cancer diagnosis, or a history of invasive cancer (except certain skin cancers), unless they were treated with curative intent and have had no signs or symptoms of cancer for at least five years.
• People with an active infection in their body or at the planned surgery site.
• People with insulin-dependent diabetes.
• People who smoke and do not agree to stop before surgery.
• People with chronic or acute kidney failure, or a significant history of kidney disease.
• People assessed as not having the mental capacity to participate (confirm with trial site).
• People who are currently imprisoned.
• People currently or recently in treatment for alcohol or drug dependency.
• People involved in current or pending legal action related to a spinal condition.
• People who have taken medications that may affect bone metabolism, such as steroids or methotrexate, within two weeks before the planned surgery date.
• People with a history of hormonal or metabolic disorders known to affect bone formation, such as Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta.
• People who would need to take medications after surgery that could affect the stability of the implant, such as long-term steroids.
• People who have received an experimental treatment within 28 days before the surgery, or who plan to receive one within 16 weeks after receiving the study device.

Important: Always verify eligibility with the trial site directly before applying.