Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the effectiveness of the Biomet Lumbar Spinal Fusion System in patients undergoing lumbar fusion surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Posterior Lateral Fusion (PLF) With Dynesys

NCT00791180

Spondylolisthesis

COMPLETED

A Clinical Study of the Dynesys(R) Spinal System

NCT00759057

Degenerative Spondylolisthesis or Retrolisthesis Spinal Stenosis Stenosing Lesion.

TERMINATED PHASE3

Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion.

NCT00215319

Degenerative Disc Disease

COMPLETED PHASE3

Clinical and Radiological Outcomes of Posterior Cervical Fusion with Medtronic Infinity Occipitocervical-Upper Thoracic (OCT) System

NCT04056520

Degenerative Disc Disease

COMPLETED

Spine Patient Outcomes Registry for Biomet/EBI (Electro-Biology, Inc)

NCT00726284

Degenerative Disc Disease Spinal Stenosis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

All subjects enrolled in this study will receive the The Biomet Osteobiologic Treatment System which is comprised of the SpF® Spine Fusion Stimulator and any or all of the following can be utilized in the study: any Pedicle Screw System, autograft and an Interbody Spacer

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Degenerative Disc Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. The subject must, in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
2. The subject must be diagnosed with degenerative disc disease at up to 2 levels from L2-S1 inclusive and undergoing up to 2 level posterior lumbar spinal fusion surgery with or without anterior column fusion.
3. Subjects must be between 18 and 75 years of age.
4. The patient must be skeletally mature (epiphyses closed).

Exclusion Criteria

1. Subject is pregnant, lactating or interested in becoming pregnant during the duration of the study.
2. Any active litigation.
3. Subject is currently involved in another investigational study.
4. Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
5. Subject is incarcerated.
6. More than 2 prior spine surgeries/revision surgeries or any previous spinal fusions at levels being currently treated.
7. Traumatic instability.
8. Any parathyroid or metabolic bone disease.
9. Any active malignancy.
10. Osteopenia/Osteoporosis - All subjects will be screened for osteoporosis using SCORE (Simple Calculated Osteoporosis Risk Estimation) with a threshold value of 6. All subjects with a SCORE value greater than 6 will be referred for Dual-energy X-ray absorptiometry (DEXA) Scan. Subjects with a T-Score of £-1-2.5 will be excluded.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No