Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00018876
Status:
COMPLETED
Last Update Posted:
2013-06-07
First Post:
2001-07-05
Brief Title:
Low-Dose Radiation to Prevent Complications of Back Surgery
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Radiotherapy to Prevent Fibrosis After Lumbar Laminectomy
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
More than 10000 people each year in the United States have failed back surgery syndrome caused by scars that form around the outer surface of the spinal cord Such scarring known as peridural fibrosis is common after back surgery known as either lumbar discectomy or laminectomy Peridural fibrosis may cause recurring low back pain or leg pain after surgery Operating again to remove the scar tissue often leads to more scarring
Researchers have not previously studied radiation as a way to prevent peridural fibrosis We will test whether low-dose radiation given 24 hours before surgery will decrease the amount of peridural fibrosis and if this reduction will lead to improved results of surgery Half of the participants will receive radiation before surgery and the other half will not We will evaluate patients at followup visits 1 3 6 and 12 months after surgery with a physical exam and questionnaire At 12 months we will obtain magnetic resonance imaging MRI of the lower spine
Researchers have not previously studied radiation as a way to prevent peridural fibrosis We will test whether low-dose radiation given 24 hours before surgery will decrease the amount of peridural fibrosis and if this reduction will lead to improved results of surgery Half of the participants will receive radiation before surgery and the other half will not We will evaluate patients at followup visits 1 3 6 and 12 months after surgery with a physical exam and questionnaire At 12 months we will obtain magnetic resonance imaging MRI of the lower spine
Detailed Description:
Researchers have long known that low-dose radiation inhibits fibroblast and osteoblast activity Studies in humans have shown that perioperative radiation therapy is a useful way to prevent both keloid and heterotopic bone formation However researchers have not previously studied radiation as a means to inhibit peridural fibrosis Our previous studies of both rat and dog models showed a significant reduction in peridural fibrosis after laminectomy using low-dose external beam radiation 700 cGy given 24 hours prior to surgery Based on our results from these animal studies we will test whether 1 low-dose radiation given 24 hours before surgery will decrease the amount of peridural fibrosis in people and 2 this reduction in peridural fibrosis will lead to improved results of surgery
For this study we will enroll 46 patients with failed back surgery syndrome believed to be secondary to perineural fibrosis in a randomized double-blinded controlled clinical trial We will assign patients to one of two groups before surgery preoperative radiation treatment group or no preoperative radiation control group We will treat half of the patients with external beam radiation before re-exploration and decompression of their peridural fibrosis treatment group and perform re-exploration and decompression in the other half without preoperative radiation control group
All patients will undergo simulation radiation treatment planning and will not know if they received radiation or not For patients randomized to receive preoperative radiation we will administer a single dose of 700 cGy to a 60-cm-wide field centered on the spinal cord at the affected level using a 6 MV Varian 600C linear accelerator We will administer treatment with two fields angled 45 degrees from the vertical plane so that the skin surface for the proposed incision will not be irritated This should prevent any wound healing problems Only the radiation oncologist and research assistant will know whether radiation was administered The patient and the surgeon will be masked as to the treatment
The neurosurgeon co-investigators will perform the same surgical procedure on all patients 24 hours after their radiation or sham treatment We will give all patients preoperative antibiotics The surgeon will reopen the previous midline posterior lumbar skin incision and dissect the subcutaneous tissue away from the spinous process and laminae Once the surgeon has adequately exposed the previous surgical site he or she will place a self-retaining retractor The surgeon will decompress the nerve by removing the scar tissue from around the nerve root and thecal sac The surgeon will also remove any intravertebral disc material thought to be causing nerve root compression On completion of the operation the surgeon will stop bleeding with electrocautery irrigate the wound with antibiotic and close the wound in layers In general the hospital stay after surgery is one night The patient begins gradual ambulation on the evening of surgery
We will administer the North American Spine Society NASS Lumbar Spine Outcome Assessment to patients before treatment and at followup visits to assess their physical functioning We will also use the NASS questionnaire to collect demographic and lifestyle information at baseline and to assess patient expectations regarding treatment and level of satisfaction with the treatment during the followup period We will do a physical examination and administer the patient-reported questionnaire prior to surgery and at 1 3 6 and 12 months after surgery We will obtain magnetic resonance MR imaging of the lumbar spine 12 months after treatment
For this study we will enroll 46 patients with failed back surgery syndrome believed to be secondary to perineural fibrosis in a randomized double-blinded controlled clinical trial We will assign patients to one of two groups before surgery preoperative radiation treatment group or no preoperative radiation control group We will treat half of the patients with external beam radiation before re-exploration and decompression of their peridural fibrosis treatment group and perform re-exploration and decompression in the other half without preoperative radiation control group
All patients will undergo simulation radiation treatment planning and will not know if they received radiation or not For patients randomized to receive preoperative radiation we will administer a single dose of 700 cGy to a 60-cm-wide field centered on the spinal cord at the affected level using a 6 MV Varian 600C linear accelerator We will administer treatment with two fields angled 45 degrees from the vertical plane so that the skin surface for the proposed incision will not be irritated This should prevent any wound healing problems Only the radiation oncologist and research assistant will know whether radiation was administered The patient and the surgeon will be masked as to the treatment
The neurosurgeon co-investigators will perform the same surgical procedure on all patients 24 hours after their radiation or sham treatment We will give all patients preoperative antibiotics The surgeon will reopen the previous midline posterior lumbar skin incision and dissect the subcutaneous tissue away from the spinous process and laminae Once the surgeon has adequately exposed the previous surgical site he or she will place a self-retaining retractor The surgeon will decompress the nerve by removing the scar tissue from around the nerve root and thecal sac The surgeon will also remove any intravertebral disc material thought to be causing nerve root compression On completion of the operation the surgeon will stop bleeding with electrocautery irrigate the wound with antibiotic and close the wound in layers In general the hospital stay after surgery is one night The patient begins gradual ambulation on the evening of surgery
We will administer the North American Spine Society NASS Lumbar Spine Outcome Assessment to patients before treatment and at followup visits to assess their physical functioning We will also use the NASS questionnaire to collect demographic and lifestyle information at baseline and to assess patient expectations regarding treatment and level of satisfaction with the treatment during the followup period We will do a physical examination and administer the patient-reported questionnaire prior to surgery and at 1 3 6 and 12 months after surgery We will obtain magnetic resonance MR imaging of the lumbar spine 12 months after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-057 | US NIH GrantContract | None | httpsreporternihgovquickSearchR21AR047121 |
| R21AR047121 | NIH | None | None |