RecruitingPhase 4ACTRN12611000646943

A multi-center, prospective, randomised controlled trial comparing the efficacy and safety of PRODISC-C implant to anterior cervical discectomy and fusion (ACDF) surgery, in the treatment of symptomatic cervical disc disease (SCDD)

A multi-center, prospective, randomised controlled trial comparing the efficacy and safety of PRODISC-C (Registered Trade Mark) implant to anterior cervical discectomy and fusion (ACDF) surgery, in the treatment of symptomatic cervical disc disease (SCDD)

Sponsor

Synthes Asia Pacific

Enrollment

300 participants

Start Date

Apr 23, 2008

Study Type

Interventional

Conditions

Symptomatic cervical disc disease (SCDD)

Summary

The PRODISC-C is intended to replace diseased and/or degenerated intervertebral discs of the cervical spine in patients with SCDD. PRODISC-C is intended to significantly reduce pain by allowing for the removal of the diseased disc while restoring disc height and providing the potential for motion at the affected vertebral segment. The primary hypothesis of this study is that, in regard to key clinical outcomes, the PRODISC-C implant is not inferior (non-inferior) to ACDF surgery.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares a cervical disc replacement implant (called ProDisc-C) with the standard surgical treatment for neck disc disease (anterior cervical discectomy and fusion, or ACDF). When a disc in the neck wears out and presses on a nerve, it can cause neck pain, arm pain, and weakness. The new implant is designed to relieve pain while still allowing movement in the neck, unlike the fusion procedure that locks the vertebrae together. You may be eligible if: - You are between 18 and 65 years of age - You have neck or arm pain caused by a diseased disc at a single level between C3 and C7 in your neck - The problem has been confirmed on a scan (CT, MRI, or X-ray) - Non-surgical treatments have not helped after about 6 weeks, or your symptoms are getting worse - Your neck disability score is 30% or higher (moderate disability) You may NOT be eligible if: - More than one level of your neck requires treatment - You have severe facet joint disease in the neck - You have a known allergy to cobalt, chromium, molybdenum, titanium, or polyethylene - You have osteoporosis or another metabolic bone disease - You have insulin-dependent diabetes, a rheumatic disease, or an active infection - You are pregnant Talk to your doctor about whether this trial might be right for you.

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Interventions

ProDisc-C implant (replacement of diseased disc), Cervios (cage) for fusion post discectomy. These are two separate implants used for comparison in the trial. Subjects are randomised into either the

ProDisc-C implant (replacement of diseased disc), Cervios (cage) for fusion post discectomy. These are two separate implants used for comparison in the trial. Subjects are randomised into either the ProDisc-C arm or the Cervios arm just prior to the surgery. ProDisc-C is a device based on a ball and socket design. It is made up of 3 parts - the 1st is the inferior cobalt chromium molybdenum alloy plate with a midline keel which is anchored into the endplate of the inferior vertebral body. The 2nd component is an ultra high molecular weight polyethylene insert that is snap-locked into a tray detail in the inferior alloy plate and provides the inferior convex bearing surface. The 3rd component is a cobalt chromium molybdenum alloy plate with a midline keel that anchors to the superior vertebral body and has a highly polished concave bearing surface that articulates with the convex spherical dome. The implant is permanent and surgical intervention is a one-off procedure, which requires 2 to 3 hours of surgery time. After removal of the diseased cervical disc, the alternative procedure for PRODISC-C is the insertion of a device called a Cervios cage into the space to fuse the adjacent vertebrae together. Cervios is a radiolucent interbody fusion implant made of polyetheretherketone (PEEK) which has either a curved or wedge-shaped profile to fit into the inter-vertebral cervical disc space for anterior interbody fusion. The implant has a large round window in its middle to allow for bone through-growth or, the spacing can be packed with bone substitutes. The implant is conventionally referred to a "cage". Compared to Cervios, the ball and socket design of ProDisc-C is for motion preservation, that is, the implant offers the potential of allowing for disc removal without increasing the stress and strain on adjacent cervical segments.

Locations(5)

Seoul, Korea, Republic Of

Beijing, China

New Territories, Hong Kong

Lower Kent Ridge Road, Singapore

Taipei, Taiwan, Province Of China

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ACTRN12611000646943