Rajasekaran 2013.
Methods | Singe‐centre RCT Setting: Department of Orthopaedics and Spine Surgery, Ganga Hospital, Coimbatore, Tamil Nadu Country: India Period: not reported |
|
Participants |
Number: 51 patients (28/23) Diagnosis: MRI exam correlating with typical neurogenic claudication symptoms due to degenerative lumbar canal stenosis Included: degenerative lumbar canal stenosis affecting 3 or less levels; typical neurogenic claudication symptoms; MRI demonstrating good clinical correlation; and failure of conservative methods of treatment for a minimum period of 6 months Excluded: spondylolisthesis with slip Meyerding grade 2 or greater; instability at the level of stenosis (as defined by > 3 mm translation or > 10° angular change on flexion extension lateral radiographs); concomitant symptomatic cervical or thoracic stenosis; comorbidities such as cardiopulmonary insufficiency; peripheral neuropathy; peripheral vascular disease, prior lumbar spine surgery; severe hip or knee disease Age (years): mean (SD) 57.3 (11.2)/54.5 (8.2) |
|
Interventions |
Group 1: lumbar spinous process splitting decompression. In the experimental group, the interspinous and supra spinous ligaments were cut longitudinally in line with the spinous processes, then decompression proceeded according to the conventional method Group 2: conventional midline decompression. In the conventional decompression group the overhanging portion of the proximal spinous process, the interspinous and the supraspinous ligaments were removed, and the ligamentum flavum and the distal half of the proximal lamina were excised. Facetal undercutting was performed as needed Follow‐up: 16 months |
|
Outcomes |
Pain: 10 cm VAS leg pain (neurogenic claudication) Disability: JOA Recovery Operation time Perioperative blood loss Complications Reoperations Length of hospital stay |
|
Notes |
Surgeon's experience: not reported Funding: "AO Spine India research grant and the Ganga Orthopaedic Research and Education Foundation funds were received in support of this work" |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "the study was a prospective randomized controlled study" and "surgical treatment method for the patients was determined by an automated computer‐generated block randomization chart." |
Allocation concealment (selection bias) | Unclear risk | Not mentioned. |
Blinding of participants (performance bias) All outcomes | Unclear risk | No mention of any attempts to blind the participants. |
Bliding of personnel/ care providers (performance bias) | High risk | The surgeon could not have been blinded to the intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "patients outcomes were assessed by an independent observer who was blinded to the type of surgery that a particular patient has undergone." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 100% of the patients completed the follow‐up. |
Intention‐to‐treat analysis (attrition bias) | Unclear risk | No information about intention‐to‐treat analysis. |
Selective reporting (reporting bias) | Low risk | All expected outcomes were reported. |
Group similarity at baseline (selection bias) | Low risk | Patients did not differ in their baseline characteristics, based on Tables 1, 2 and 4. |
Co‐interventions (performance bias) | Low risk | Only the surgical technique differed between treatment groups. |
Compliance (performance bias) | Low risk | Compliance in both treatment groups: 100% (surgery). |
Timing of outcome assessment (detection bias) | Unclear risk | Quote: "the mean duration of follow‐up was 14.2 ± 2.9 months (12–16 mo)." |
Other bias | Unclear risk | Quote: "AO Spine India research grant and the Ganga Orthopaedic Research and Education Foundation funds were received in support of this work." |