Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT01455805
Eligibility Criteria:
Inclusion Criteria:
* Is male or a non pregnant female aged 18years or older
* BMI ≤ 35kg/m2
* Has chronic leg pain with or without back pain of greater than 6 months duration,which is partially or completely relieved by either sitting or adopting a flexed posture and who are suitable in the clinicians opinion for posterior lumbar surgery
* Pre-operative ODI score ≥ 20%
* Pre-operative ZCQ Physical Function Domain ≥2
* Pre-operative VAS Leg pain score ≥ 4
* Has completed at least 6 months of conservative treatment without obtaining adequate symptomatic relief or has worsening neurological symptoms.
* Has degenerative changes at 1 or 2 levels confirmed by MRI or CT Myelogram within the last 12 months) with one or more of the following:
* Lumbar spinal stenosis with intermittent neurogenic claudication
* Degeneration of the disc (as evidenced by imaging on MRI)
* Annular thickening
* Degenerative Spondylolisthesis ≤ Meyerding Grade 1
* Thickening of ligamentum flavum
Exclusion Criteria:
* Fixed motor deficit
* Has undergone previous lumbar spinal surgery
* Is unwilling or unable to give consent or adhere to the follow up schedule
* Has active infection or metastatic disease
* Has spondylolisthesis \> grade 1
* Has neurogenic bladder or bowel disease
* Has a history of Osteopenia and or Osteoporosis. Evaluation of possible Osteopenia and or Osteoporosis will be conducted via a bone density scan prior to randomisation if ANY of the Bone Mass Evaluation criteria is met
* Patients who are not deemed fit for anaesthesia/major surgery due to underlying medical condition
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01455805
Study Brief:
Protocol Section:
NCT01455805