Lumbar Discectomy Control Study, Risk Factors for Reherniation

NCT02477176 | Unknown DMC

• 1 other identifier: US CONTROL-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this 12-month, prospective, multicenter study is to investigate the effect of annular defect size and other risk factors on reherniation and associated costs in primary lumbar discectomy patients.

Conditions

Lumbar Spine Disc Herniation

Outcome Measures

Primary Outcomes (1)

• Lumbar reherniation at the index level

  Reherniation of index level, yes or no

  12 Months

Secondary Outcomes (2)

• Reoperation at the index level

  12 Months

• Hospitalization at physician cost

  12 Months

Study Arms (2)

Small annular defect group

Patients with lumbar defect less than 6mm wide after lumbar discectomy

Other: Discectomy

Large annular defect group

Patients with lumbar defect greater than 6mm wide after lumbar discectomy

Other: Discectomy

Interventions

Discectomy OTHER

Lumbar discectomy

Large annular defect group; Small annular defect group

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with single level, symptomatic lumbar disc herniation

You may qualify if:

• Age 21 to 75 years old and skeletally mature (male or female).
• Patients with posterior or posterolateral disc herniations at one level between L1 and S1 with radiographic confirmation of neural compression using MRI. \[Note: Intraoperatively, only patients with an annular defect (post discectomy) between 4mm and 6mm tall and 6mm and 10mm wide shall qualify.\]
• Radiculopathy (with or without back pain) with a positive Straight Leg Raise (0 - 60 degrees)22 (L45, L5S1) or Femoral Stretch Test (L12, L23, L34)
• Oswestry Questionnaire score of at least 40/100 at baseline.
• VAS leg pain (one or both legs) of at least 40/100 at baseline.
• Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
• Minimum posterior disc height of 5mm at the index level.

You may not qualify if:

• Spondylolisthesis Grade II or higher (25% slip or greater).
• Subject requires spinal surgery other than a discectomy (with or without laminotomy) to treat leg/back pain (scar tissue and osteophyte removal is allowed).
• Subject has back or non-radicular leg pain of unknown etiology.
• Prior surgery at the index lumbar vertebral level.
• Subject requiring a spine dual energy x-ray absorptiometry (i.e., patients with SCORE of ≥ 6) with a T Score less than -2.0 at the index level. For patients with a herniation at L5/S1, the average T score of L1-L4 shall be used.
• Subject has clinically compromised vertebral bodies in the lumbosacral region due to any traumatic, neoplastic, metabolic, or infectious pathology.
• Subject has sustained pathologic fractures of the vertebra or multiple fractures of the vertebra or hip.
• Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).
• Any metabolic bone disease.
• Subject has an active infection either systemic or local.
• Subject has cauda equine syndrome or neurogenic bowel/bladder dysfunction.
• Subject has severe arterial insufficiency of the legs or other peripheral vascular disease. (Screening on physical examination for patients with diminution or absence of dorsalis pedis or posterior tibialis pulses. If diminished or absent by palpation, then an arterial ultrasound is required with vascular plethysmography. If the absolute arterial pressure is below 50mm of Hg at the calf or ankle level, then the patient is to be excluded.)
• Subject has significant peripheral neuropathy, patient defined as a patient with Type I or Type II diabetes or similar systemic metabolic condition causing decreased sensation in a stocking-like or non-radicular and non-dermatomal distribution in the lower extremities.
• Subject has insulin-dependent diabetes mellitus.
• Subject is morbidly obese (defined as a body mass index \>40, or weighs more than 100 lbs over ideal body weight).

Sponsors & Collaborators

• Intrinsic Therapeutics: lead

Study Sites (4)

Midwest Orthopaedics at Rush Medical Center

Chicago, Illinois, 60612, United States

Location

Orthopaedic Specialists Of The Four States

Galena, Kansas, 66739, United States

Location

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42001, United States

Location

Michigan Orthopedic Specialists

Dearborn, Michigan, 48124, United States

Location

MeSH Terms

Interventions

Diskectomy

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative

Study Officials

• David H Kim, MD

  New England Baptist Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 22, 2015
• Study Start: February 17, 2016
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2025
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

US (4)