A Prospective, Randomized, Controlled, Multi-center, (Pilot) Study of Osigraft® in Instrumented Posterolateral Fusions

niversity Medical Center Utrecht0 sites150 target enrollmentNovember 2, 2005

DrugsOsigraft

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: niversity Medical Center Utrecht
Enrollment: 150
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 2, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity Medical Center Utrecht

Eligibility Criteria

Inclusion Criteria

•1\) Diagnosis of Degenerative and/or Isthmic Spondylolisthesis and/or Degenerative Disc Disease (DDD) at the levels of L3\-S1 with (a) Lumbar instability of at least 2 to 3 mm translation in standing standard radiographs or (b) at least 2 to 3 mm translation in flexion extension radiograms29,30 and/or angulation motion defined as \>15° at L3\-L4 level, \>18° at L4\-L5 level, and \>17° at L5\-S1 spine level.
•2\) Leg and/or back pain with one or more of the following phenomena: radiculopathy, sensory deficit, motor weakness, reflex pathology, neurogenic claudication;
•3\) The subject has been non\-responsive to at least 6 months of non\-operative treatment prior to study enrollment;
•4\) The subject has a preoperative Oswestry Disability Index of 30\-100;
•5\) Fusion of only one lumbar level in the L\-3 to S\-1 region is indicated;
•6\) The subject has no history of previous fusion attempt(s) to the affected spinal level;
•7\) The subject is willing and able to understand, sign and date the study specific Patient Informed Consent, which has been approved by the Institutional Review Board;
•8\) The subject agrees to comply with post\-operative clinical and radiographic evaluations and required rehabilitation regimen;
•9\) Age: the subject is skeletally mature between 18 and 80 years of age;
•10\) Gender: both males and females can be included in the study.

Exclusion Criteria

•1\) The subject has gross instability as a result of Degenerative and/or Isthmic Spondylolisthesis and/or DDD that requires multiple levels fusion (an example would be exclusion of Grade IV Spondylolisthesis);
•2\) The subject is severely osteoporotic/osteopenic as manifested by the presence of a history of osteoporotic spine fractures and/or medical treatment for osteoporosis and/or such changes on the AP/lateral radiographs that will make the surgeon decide to exclude this patient from any form of pedicle fixation;
•3\) The subject has an active spinal and/or systemic infection;
•4\) The subject has a systemic disease or condition, which would affect his/her ability to participate in the study requirements or the ability to evaluate the efficacy of the investigational product (i.e., active malignancy, neuropathy);
•5\) The subject is a prisoner, a transient or has been treated for alcohol and/or drug abuse in an inpatient substance abuse program within six months prior to proposed study enrollment;
•6\) The subject has participated in clinical trials evaluating investigational devices, pharmaceuticals or biologics within 3 months of enrollment in the study;
•7\) The subject is a woman who intends to bear children within 1 year of enrolling in the study (e.g. is not post\-menopausal, has not had a hysterectomy, is not on long term oral contraception);
•8\) The subject is morbidly obese (defined as weight \>60 percent over the recommended ideal weight as described in the 1996 Metropolitan Height and Weight Tables for Men and Women;
•9\)The subject has a known sensitivity to any component of Osigraft®;
•10\) The subject is known to require at the time of treatment, additional surgery to the lumbar spinal region within the next six months;