TerminatedNot Applicable

Novum Vitrium® Cervical Cage in Anterior Cervical Discectomy and Fusion

Stopped: Sponsor business decision

United States25 participantsStarted 2019-04-24

Plain-language summary

A prospective, multicenter, randomized, concurrently controlled, noninferiority clinical trial to compare the safety and effectiveness of instrumented Bio2 Vitrium Cervical Interbody Device in anterior cervical discectomy and fusion (ACDF) with structural allograft bone and local autologous bone graft in treating patients with a symptomatic degenerative cervical disc disease at one level from C3/C4 to C7/T1.

Who can participate

Age range22 Years – 70 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

✓. Symptomatic cervical disc disease (SCDD) in the one vertebral level between C3/C4 to C7/T1, defined as neck or arm (radicular) pain, or functional or neurological deficit and correlated with radiculopathy or myelopathy or radiographic confirmation (by CT, MRI, x-ray, etc.) of any of the following:
✓. Requires only one cervical vertebral level to be surgically treated, confirmed radiologically by Xray, CT, or MRI and correlated with neurologic examination prior to enrollment;
✓. Age between 22 and 70 years (inclusive);
✓. Skeletally mature patients;
✓. Failed at least 6 weeks of conservative treatment (e.g. medication, physical therapy), or exhibit progressive symptoms or signs of spinal cord/nerve root compression with continued non-operative care;
✓. Neck Disability Index (NDI) Questionnaire score of at least 30 (on a scale from 0 to 100);
✓. Able to read and Understand all documents used in this study, including the Informed Consent and patient-reported outcome questionnaires;
✓. Understand and read English at elementary level;

Exclusion criteria

What they're measuring

Number of participants who have achieved of radiologic fusion assessed by roentgenographic examination.

Timeframe: 12 months

Change in Neck Disability Index (NDI) with a response greater than or equal to 15 from baseline.

Timeframe: 12 months

Number of participants with neurological success.

Timeframe: 12 months

Number of participants who have completed follow-up up to month 12 without Secondary Surgical Intervention (SSI).

Timeframe: 12 months

Trial details

NCT IDNCT03828136

SponsorBio2 Technologies

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-21

View on ClinicalTrials.gov More Symptomatic Cervical Disc Disease trials

Plain-language summary

Who can participate

Age range22 Years – 70 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

✓. Symptomatic cervical disc disease (SCDD) in the one vertebral level between C3/C4 to C7/T1, defined as neck or arm (radicular) pain, or functional or neurological deficit and correlated with radiculopathy or myelopathy or radiographic confirmation (by CT, MRI, x-ray, etc.) of any of the following:
✓. Requires only one cervical vertebral level to be surgically treated, confirmed radiologically by Xray, CT, or MRI and correlated with neurologic examination prior to enrollment;
✓. Age between 22 and 70 years (inclusive);
✓. Skeletally mature patients;
✓. Failed at least 6 weeks of conservative treatment (e.g. medication, physical therapy), or exhibit progressive symptoms or signs of spinal cord/nerve root compression with continued non-operative care;
✓. Neck Disability Index (NDI) Questionnaire score of at least 30 (on a scale from 0 to 100);
✓. Able to read and Understand all documents used in this study, including the Informed Consent and patient-reported outcome questionnaires;
✓. Understand and read English at elementary level;

Exclusion criteria

What they're measuring

Number of participants who have achieved of radiologic fusion assessed by roentgenographic examination.

Timeframe: 12 months

Change in Neck Disability Index (NDI) with a response greater than or equal to 15 from baseline.

Timeframe: 12 months

Number of participants with neurological success.

Timeframe: 12 months

Number of participants who have completed follow-up up to month 12 without Secondary Surgical Intervention (SSI).

Timeframe: 12 months