CompletedNot Applicable

INFUSE™ BONE GRAFT/CORNERSTONE-SR™ Allograft Ring/ATLANTIS™ Anterior Cervical Plate- Pilot Study

33 participantsStarted 1999-09

Plain-language summary

The purpose of this clinical trial is to assess the safety and effectiveness of the Investigational implant as compared to the Control implant in the treatment of patients with one level or two adjacent levels of cervical symptomatic degenerative disc disease.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Cervical disc disease defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by diagnostic imaging procedures:
✓. Has preoperative Neck Disability Index score \>= 30;
✓. C2-C3 disc to C7-Tl disc level(s) of involvement.
✓. One or two adjacent levels requiring fusion;
✓. No previous surgical intervention at the involved fusion level(s);
✓. Unresponsive to nonoperative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root or spinal cord compression in face of continued nonoperative management;
✓. Age \> 18 years at time of surgery;
✓. Is female of child-bearing potential, who is not pregnant or nursing, and who agrees to not get pregnant for 1 year following surgery;

Exclusion criteria

✕. Has cervical spinal condition requiring surgical treatment other than symptomatic cervical disc disease at the involved level(s).
✕. Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that anterior plating would be contraindicated.
✕. Has presence of spinal metastases.
✕. Has overt or active bacterial infection, either local or systemic.
✕. Has fever (temperature \> 101°F oral) at the time of surgery.
✕. Has a documented titanium alloy allergy or intolerance.
✕. Is mentally incompetent. If questionable, obtain psychiatric consult.
✕. Is a prisoner.

What they're measuring

Fusion

Timeframe: 24 month

Pain/Disability Status

Timeframe: 24 month

Neurological Status

Timeframe: 24 month

Trial details

NCT IDNCT01491399

SponsorMedtronic Spinal and Biologics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2003-03

View on ClinicalTrials.gov More Degenerative Cervical Disc Disease trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Cervical disc disease defined as: intractable radiculopathy and/or myelopathy with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by diagnostic imaging procedures:
✓. Has preoperative Neck Disability Index score \>= 30;
✓. C2-C3 disc to C7-Tl disc level(s) of involvement.
✓. One or two adjacent levels requiring fusion;
✓. No previous surgical intervention at the involved fusion level(s);
✓. Unresponsive to nonoperative treatment for approximately six weeks or has the presence of progressive symptoms or signs of nerve root or spinal cord compression in face of continued nonoperative management;
✓. Age \> 18 years at time of surgery;
✓. Is female of child-bearing potential, who is not pregnant or nursing, and who agrees to not get pregnant for 1 year following surgery;

Exclusion criteria

✕. Has cervical spinal condition requiring surgical treatment other than symptomatic cervical disc disease at the involved level(s).
✕. Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that anterior plating would be contraindicated.
✕. Has presence of spinal metastases.
✕. Has overt or active bacterial infection, either local or systemic.
✕. Has fever (temperature \> 101°F oral) at the time of surgery.
✕. Has a documented titanium alloy allergy or intolerance.
✕. Is mentally incompetent. If questionable, obtain psychiatric consult.
✕. Is a prisoner.