Incidence of Lumbar Spondylolisthesis in Patients Candidate for TKR

NCT05464134 | Unknown

• 1 other identifier: Lumbar Spondylolisthesis & TKR
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to detect the incidence of spondylolisthesis in patients candidate for Total knee replacement (TKR) and to investigate the effect of TKR on the course of low back pain.

Conditions

Lumbar Spondylolisthesis

Outcome Measures

Primary Outcomes (3)

• Incidence of lumbar spine spondylolisthesis.

  showing the incidence and occurrence of Lumbar Spondylolisthesis in patients with severe knee Osteoarthritis which needs Total knee replacement

  Baseline

• Severity of lumbar spine spondylolisthesis.

  showing the grades of lumbar spine spondylolisthesis through The Meyerding classification system with grade 1 is the minimum and grade 5 is the maximum which in turn has the worst outcome

  Baseline

• occurence of lumbar spine spondylolishtesis Occurrence of lumbar spine spondylolisthesis

  Showing the occurrence of lumbar spine spondylolisthesis in patients with severe osteoarthritis which needs total knee replacement

  Baseline

Secondary Outcomes (3)

• Change in characters of low back pain over the postoperative period.

  6 months follow up

• Spine radiological features.

  Baseline

• Knee radiological and alignment features.

  Baseline

Interventions

x-ray RADIATION

plain radiographs of lower limb anteroposterior and lateral views , lumbar spine plain radiographs (anteroposterior, lateral, lateral in flexion and lateral in extension views )

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The sample size was calculated using STAT CALC based on the previous work by Chang et al., 2014 (4), by considering the following assumptions:- 95% two-sided confidence level, with a power of 80% \& Alpha error of 5% odds ratio calculated= 1.115. The final maximum sample size was 200

You may qualify if:

• primary end-stage knee osteoarthritis.

You may not qualify if:

• secondary inflammatory knee osteoarthritis.
• post traumatic knee osteoarthritis.
• patients with active infection.
• patients with poor general condition.
• patients who had previous spinal fixation or fusion surgery.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Kahlenberg CA, Nwachukwu BU, McLawhorn AS, Cross MB, Cornell CN, Padgett DE. Patient Satisfaction After Total Knee Replacement: A Systematic Review. HSS J. 2018 Jul;14(2):192-201. doi: 10.1007/s11420-018-9614-8. Epub 2018 Jun 5.

  PMID: 29983663 BACKGROUND

• Patel EA, Perloff MD. Radicular Pain Syndromes: Cervical, Lumbar, and Spinal Stenosis. Semin Neurol. 2018 Dec;38(6):634-639. doi: 10.1055/s-0038-1673680. Epub 2018 Dec 6.

  PMID: 30522138 BACKGROUND

• Londhe SB, Shah RV, Patwardhan M, Doshi AP, Londhe SS, Subhedar K, Kundnani V, Patel J. Study of Patients with Bilateral Knee Osteoarthritis Undergoing Total Knee Replacement Procedure with Coexisting Lumbar Spondylosis Symptoms. Asian Spine J. 2021 Dec;15(6):825-830. doi: 10.31616/asj.2020.0279. Epub 2020 Dec 28.

  PMID: 33355851 BACKGROUND

• Chang CB, Park KW, Kang YG, Kim TK. Coexisting lumbar spondylosis in patients undergoing TKA: how common and how serious? Clin Orthop Relat Res. 2014 Feb;472(2):710-7. doi: 10.1007/s11999-013-3298-7. Epub 2013 Sep 25.

  PMID: 24065173 BACKGROUND

Related Links

• Decompression with or without fusion in degenerative lumbar spondylolisthesis

MeSH Terms

Conditions

Spondylolisthesis

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Central Study Contacts

Mario Sameh Wadie, physician

CONTACT

+201271972023; mariowadeeeeee3@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: July 19, 2022
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 19, 2023

Record last verified: 2023-05