TELAMON P™ Implant/INFUSE® Bone Graft/CD HORIZON® Spinal System Pilot Study

NCT01491516 | Completed DMC

• 1 other identifier: P01-07
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this pilot study is to evaluate the feasibility of the implant ( TELAMON P™ Implant/INFUSE Bone Graft System used in conjunction with the CD HORIZON® Spinal System) as a method of facilitating lumbar spinal fusion utilizing a posterior surgical approach in patients with symptomatic degenerative disc disease. The safety and effectiveness of the implant will be evaluated.

Conditions

Degenerative Disc Disease

Keywords

Lumbar degenerative disc disease

Outcome Measures

Primary Outcomes (1)

• Overall Success

  A patient will be considered an overall success if all of the following conditions are met: 1. fusion; 2. pain/disability (Oswestry) success; 3. neurological status success; 4. no serious adverse event classified as "implant associated" or "implant/surgical procedure associated"; 5. no additional surgical procedure classified as a "failure".

  24 month

Secondary Outcomes (5)

• Disc Height Measurement

  24 month

• General Health Status (SF-36)

  24 month

• Pain Status (back pain, leg pain)

  24 month

• Patient Satisfaction

  24 month

• Patient Global Perceived Effect

  24 month

Study Arms (1)

Investigational

EXPERIMENTAL

Device: TELAMON P™ /INFUSE® Bone Graft/CD HORIZON® Spinal System

Interventions

TELAMON P™ /INFUSE® Bone Graft/CD HORIZON® Spinal System DEVICE

The TELAMON P™/INFUSE™ Bone Graft Implant in conjunction with the CD HORIZON® Spinal System for single level lumbar fusion from L1 to S1

Also known as: PEEK OPTIMA™ LT

Investigational

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history and radiographic studies to include one or more of the following:
• instability (defined as angulation \>= 5° and/or translation \>= 4mm, based on flexion/extension radiographs);
• osteophyte formation;
• decreased disc height;
• thickening of ligamentous tissue;
• disc degeneration or herniation; and/or
• facet joint degeneration.
• Has preoperative Oswestry score \>= 30.
• Has preoperative back pain score of \>= 25 based on the Preoperative Back and Leg Pain Questionnaire (intensity and duration).
• Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding, HW, 1932).
• Requires fusion of a single level disc space from L 1 to S 1.
• Is at least 18 years of age, inclusive, at the time of surgery.
• Has not responded to non-operative treatment for a period of 6 months.
• If of child-bearing potential, patient is non-pregnant, non-nursing, and agrees to not get pregnant for 1 year following surgery.
• Is willing and able to comply with the study plan and sign the Patient Informed Consent Form.

You may not qualify if:

• Has primary diagnosis of a spinal disorder other than degenerative disc disease with Grade 1 or less spondylolisthesis at the involved level.
• Had previous spinal fusion surgical procedure at the involved level.
• Requires spinal fusion at more than one lumbar level.
• Has a condition which requires postoperative medications that interfere with fusion, such as steroids or prolonged use of nonsteroidal anti-inflammatory drugs excluding routine peri-operative nonsteroidal anti-inflammatory drugs. This does not include low dose aspirin for prophylactic anticoagulation.
• 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 risk factors, a dual x-ray absorptiometry (DEXA) Scan will be required to determine eligibility).
• Postmenopausal Non-Black female over 60 years of age and weighs less than 140 pounds.
• Postmenopausal female that has sustained a non-traumatic hip, spine, or wrist fracture.
• Male over the age of 70.
• Male over the age of 60 that has sustained a non-traumatic hip or spine fracture. If the level of BMD is a T score of -3.5 or a T score of -2.5 with vertebral crush fracture, the patient is excluded from the study.
• Has presence of active malignancy or prior history of malignancy, except for basal cell carcinoma of the skin.
• Has an overt or active bacterial infection, either local or systemic.
• Has a documented titanium, titanium alloy, tantalum, tantalum alloy, or polyetheretherketone allergy or intolerance.
• Is mentally incompetent. If questionable, obtain psychiatric consult.
• Has a Waddell Signs of Inorganic Behavior score of 3 or greater.

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 14, 2011
• Study Start: July 1, 2003
• Primary Completion: April 1, 2008
• Study Completion: October 1, 2008
• Last Updated: September 18, 2018

Record last verified: 2011-12