Incidence of Large Annular Defects in Primary Lumbar Discectomy Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/1/2019 |
| Start Date: | February 2019 |
| End Date: | December 2019 |
| Contact: | Ivan Grzan, BS |
| Email: | ivan@in-thera.com |
| Phone: | 781-932-0222 |
Study to Determine Incidence of Large Annular Defects And Measurement of Volume of Nucleus Removed in Primary Discectomy Patients
Lumbar discectomy study, collection and evaluation of incidence of large annular defects.
This study is designed as a single-site prospective data collection. Measurements will be
collected during 150 consecutive standard of care primary lumbar discectomy procedures.
collected during 150 consecutive standard of care primary lumbar discectomy procedures.
Inclusion Criteria:
1. Must be 18-75 years of age, and skeletally mature
2. Must have clinical and radiological evidence of primary lumbar disc herniation at one
level of the lumbar spine between L3-S1.
3. Must be psychosocially, mentally and physically able to comply with protocol,
post-operative management and follow-up care.
4. Subject must understand and sign the written Informed Consent.
Exclusion Criteria:
1. Prior surgery at the index lumbar vertebral level.
2. Subject requires spinal surgery other than a discectomy (with or without laminotomy)
to treat leg/back pain
3. Morbid obesity (BMI ≥ 40 kg/m2)
4. Investigational drug or device use within 30 days
We found this trial at
1
site
Tampa, Florida 33607
Principal Investigator: Reginald Davis, MD
Phone: 813-392-7767
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