Background context:

Lumbar canal stenosis due to degenerative lumbar spondylolisthesis is one of the most common indications for lumbar spinal surgery. However, from a long-term perspective, it is still unclear which of these procedures should be performed: decompression, decompression plus fusion, or decompression plus stabilization.

Purpose:

This study aimed to present the long-term results of a randomized controlled trial of surgery for degenerative spondylolisthesis.

Study design/setting:

This is a long-term follow-up of a previously reported randomized controlled trial.

Patient sample:

Patients aged ≤ 75 years with single L4/5 level lumbar canal stenosis caused by degenerative lumbar spondylolisthesis were enrolled at two hospitals from May 1, 2003, to April 30, 2012; the final follow-up was on May 20, 2021.

Outcome measures:

The following data were collected: modified Japanese Orthopaedic Association (JOA) score, visual analog scale (VAS) score for lower back pain, leg pain, and numbness, and scores from eight Short-Form 36 (SF-36) subscales preoperatively, 1 year postoperatively, 5 years postoperatively, and at the final follow-up.

Methods:

Patients were randomized to undergo decompression alone, decompression plus fusion, or decompression plus stabilization. The primary outcome measure was the change in VAS for lower back pain with secondary outcomes including the modified JOA score, VAS for leg pain, VAS for leg numbness, eight SF-36 subscale scores, and occurrence of reoperation at the last follow-up.

Results:

Among 85 patients who were randomized, 66 responded to the current survey. The mean follow-up period was 12.3 years. The VAS score for low back pain improvement was not significantly different between the decompression and fusion groups at the mean follow-up of 12.3 years. Of the 12 secondary outcomes, 8 showed no significant difference between decompression and fusion, 12 showed no significant difference between decompression and stabilization, and 10 showed no significant difference between fusion and stabilization.

Conclusions:

Although additional instrumentation surgery did not significantly improve low back pain at the mean follow-up of 12.3 years compared with decompression alone, fusion surgery provided clinically meaningful improvements in patient-reported vitality, social functioning, role limitations due to personal or emotional problems, and mental health compared with decompression alone.

Trial registration:

UMIN000028114.