Survivorship of Decompression Alone Vs Decomp With Fusion in DLS and LCS

NCT05386381 | Unknown DMC

• 1 other identifier: RL1854
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

There has been a long-standing controversy on the operative treatment of Degenerative Lumbar Spondylolisthesis (DLS) with Lumbar Canal Stenosis (LCS), especially whether the addition of fusion to decompression is necessary. Many believe that decompression alone (D) by either using midline preserving fenestration techniques (fenestration by laminotomy and medial facetectomy) or with a spinous process osteotomy (SPO) is enough for treatment of patients with DLS while others believe that a fusion (D+F) should be added in all cases. The study aims to determine if decompression alone performs better or worse in the long term than decompression with fusion in a large cohort of patients who have DLS with LCS. It also aims to determine if the decompression technique of midline-sparing fenestration or spinous process osteotomy make a difference to survival in cases of DLS with LCS.

Conditions

Lumbar Spondylolisthesis Involving L4-L5

Keywords

Degenerative Lumbar Spondylolisthesis; Lumbar Canal Stenosis; Fusion; Decompression; Fenestration; Spinous Process Osteotomy

Outcome Measures

Primary Outcomes (1)

• Time to Revision

  Duration between initial surgery and revision surgery at same level

  15 years

Study Arms (2)

Decompression alone

Patients undergone decompression surgery alone

Decompression with fusion

Patient undergone decompression and lumbar fusion surgery

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with degenerative lumbar spondylolisthesis treated operatively between 1st January 2002 and 31st December 2006 at Robert Jones and Agnes Hunt Orthopaedic Hospital

You may qualify if:

• All patients with degenerative lumbar spondylolisthesis

You may not qualify if:

• Patients with spondylolysis

Sponsors & Collaborators

• Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust: lead

Study Sites (1)

Robert Jones and Agnes Hunt Orthopedic Hospital

Oswestry, SY10 7AG, United Kingdom

Location

Study Officials

• olakunle J Alonge, MBBS, FWACS

  The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS FT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 23, 2022
• Study Start: May 6, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

GB (1)