NCT00637156 - Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels | Crick

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Has cervical DDD at 2 adjacent cervical levels (C3-C7) requiring surgical treatment \& involving intractable radiculopathy, myelopathy, or both * Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history, and the requirement for surgical treatment is evidenced by radiographic studies * Unresponsive to non-operative treatment for approximately 6 weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management * Has no previous surgical intervention at the involved levels or any subsequent planned/staged surgical procedure at the involved or adjacent level(s) * Must be ≥ 18 years; skeletally mature at time of surgery * Preoperative NDI score ≥ 30 * Preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain Questionnaire * If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period * Is willing to comply with the study plan and sign Patient Informed Consent Form Exclusion Criteria: * Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical treatment at the involved levels * Has documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing: Sagittal plane translation \> 3.5 mm, or Sagittal plane angulation \> 20 degrees. * Has more than two cervical levels requiring surgical treatment * Has a fused level adjacent to the levels to be treated * Has severe pathology of the facet joints of the involved vertebral bodies * Has had previous surgical intervention at either one or both of the involved levels or at adjacent levels * Has been previously diagnosed with osteopenia or osteomalacia * Has any of the following that may be associated with a diagnosis of osteoporosis (If "Yes" to any of the below a DEXA Scan will be required to determine eligibility.) * Postmenopausal non-Black female over age of 60 who weighs \< 140 pounds * Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist fracture * Male \> 70 years * Male \> 60 years who has sustained a non-traumatic hip or spine fracture * If the level of BMD is a T score of -3.5 or lower or a T score of -2.5 or lower with vertebral crush fracture, then the patient is excluded from the study * Has presence of spinal metastases * Has overt or active bacterial infection, either local or systemic * Has insulin dependent diabetes * Is a tobacco user who does not agree to suspend smoking prior to surgery * Has chronic or acute renal failure or prior history of renal disease * Has a documented allergy or intolerance to stainless steel, titanium, or a titanium alloy * Is mentally incompetent (If questionable, obtain psychiatric consult) * Is a prisoner * Is pregnant * Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse * Is involved with current or pending litigation regarding a spinal condition * Has received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs * Has a history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta) * Has a condition that requires postoperative medications that interfere with the stability of the implant, such as steroids. (This does not include low-dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs.) * Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following implantation

Outcomes

Primary Outcomes

Rate of Overall Success

Rate of overall success is reported as the percentage of participants who met all of the following criteria: 1. Postoperative Neck Disability Index (NDI) score improvement of at least a 15-point increase from preoperative; 2. Maintenance or improvement in neurological status; 3. No serious adverse event classified as implant associated or implant/surgical procedure associated; and 4. No additional surgical procedure classified as a "failure."

Time frame: 24 Months

Secondary Outcomes

Success Rate of Neck Disability Index

Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met the following criterion: Pre-treatment Score - Post-treatment Score ≥ 15.

Time frame: 24 months

Success Rate of Neurological Status

Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must either remain the same or improve from the time of the preoperative evaluation to the time period evaluated.

Time frame: 24 months

Neck Pain Success Rate

Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met the following criterion: Preoperative Score - Postoperative Score \> 0.

Time frame: 24 months

Arm Pain Success Rate

Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met the following criterion: Preoperative Score - Postoperative Score \> 0.

Time frame: 24 months

Success Rate of SF-36 PCS

Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 PCS was defined as: Post Score - Pre Score \>= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.

Time frame: 24 months

Success Rate of SF-36 MCS

Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success of SF-36 MCS were defined as: Post Score - Pre Score \>= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.

Time frame: 24 months

Rate of Disc Height Success

Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height \>= -2mm

Time frame: 24 months

Gait Success Rate

Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score \>= 0. The gait success rate is reported as the percentage of participants who had gait success.

Time frame: 24 months

Operative Time

Operative time was recorded from skin incision to wound closure.

Time frame: Time of operation, an average of 1.7-2.1hrs

Blood Loss

Time frame: During the time of operation, an average of 1.7-2.1 hrs

Hospital Stay

Time frame: From admission to discharge, an average of 1.0-1.5 day

Rate of Secondary Surgery at Index Level

Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of subjects who had secondary surgeries at index level.

Time frame: 24 months

Change of Neck Disability Index Score From Baseline

The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Change of NDI was defined as NDI at 24 month minus NDI at baseline.