N/A
Completed N=15
Study Performance of The Plexur P™ Bone Void Filler Device in Patients Undergoing Iliac Crest Harvesting Procedures
Iliac Crest Harvesting Procedure-Bone Void Filler
Source: ClinicalTrials.gov NCT00837473 ↗
Enrolled (actual)
15
Serious AEs
80.0%
Results posted
Apr 2018
Primary outcomePrimary: Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist — 11; 4; 0; 0 Participants
Summary
The purpose of this study is to determine if Plexur P grows bone in the iliac crest (where bone was removed or "harvested") for the back surgery.
The study will be focusing on patients who require back surgery. Often additional bone is required from the hip of the patient (iliac crest). When bone removed from the hip, a "void" is often created. This "void" will be filled in with Osteotech's Plexur P product.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist |
11; 4; 0; 0; 3; 1 | — |
| SECONDARY General Health Status |
35.36; 29.41; 35.68; 41.68; 41.23; 37.43 | — |
| SECONDARY Oswestry Disability Index |
54.28; 70.19; 56.44; 44.86; 41.92; 50.80 | — |
| SECONDARY Pain Status Assessed by Visual Analog Scale (VAS) |
3.5; 2.6; 2.3; 2.4; 2.1; 2.8 | — |
| SECONDARY Surgical Related Outcome--locations of Iliac Crest Bone Harvest |
8; 7 | — |
| SECONDARY Surgical outcome-the Amount of Cancellous Bone Harvested |
14.6 | — |
| SECONDARY Surgical Outcome--operative Time |
310.0 | — |
| SECONDARY Surgical Outcome--blood Loss |
1786.7 | — |
| SECONDARY Surgical Outcome--length of Hospital Stay |
10.7 | — |
| SECONDARY Surgical Outcome- the Amount of Plexur™ P Product Utilized for Filling Void |
24.7 | — |
Eligibility Criteria
Inclusion Criteria
- The patient is at least 18 yrs old.
- The patient requires an iliac crest harvesting procedure.
- The patient has signed an Informed Consent, approved by the IRB.
Exclusion Criteria
- Patient is less than 18 years old.
- Patient presents with a bony void or gap in an area other than the iliac crest and/or has an infection present at the (operative) site.
- Insulin dependent diabetics and/or in the opinion of the investigator, has poorly controlled non-insulin dependent diabetes.
- The patient is a smoker.
- The patient is mentally compromised (e.g., currently being treated from a psychiatric disorder, senile dementia, Alzheimer's disease, etc.) and/or in the opinion of the investigator, is not likely to complete follow up visits;
- The patient has a bleeding disorder of any etiology, severe vascular or neurological disease;
- The patient has hypercalcemia and/or severe degenerative bone disease;
- The patient has a history of long term steroid use;
- The patient requires immunosuppressive therapy;
- The patient has a history of drug or alcohol abuse that may interfere with his/her ability to provide written informed consent;
- The patient is pregnant at the time of study entry or may likely become pregnant during the course of study participation;
- The subject has an implanted device, which is incompatible with the use of imaging equipment;
- The patient has an allergy to one of the components of the investigational device;
- The patient has renal insufficiency;
- The patient has a terminal illness.
Data sourced from ClinicalTrials.gov (NCT00837473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.