Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05464134
Other study ID # Lumbar Spondylolisthesis & TKR
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2023
Est. completion date June 2024

Study information

Verified date May 2023
Source Assiut University
Contact Mario Sameh Wadie, physician
Phone +201271972023
Email mariowadeeeeee3@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Total Knee Replacement (TKR) is one of the most successful surgeries in modern-day orthopedics, performed mainly to treat end-stage knee osteoarthritis (OA) . degenerative spondylolisthesis is one of the most common causes of low back pain where a spinal vertebra slides from its anatomical position, affecting about 11.5% of the population, furthermore, many elderly patients undergoing TKR usually suffer from spondylolisthesis. Spondylolisthesis with subsequent lumbar spine degenerative disease presents as lower back and radiating pain to the legs at rest or during activity, Spondylolisthesis causes hamstring tightness which is felt as pain at the back of the knee, lumbar radiculopathy of the L3 root nerve could vary from thigh pain to hip and/or knee pain, all of which could be misled as pain due to knee OA . On the other hand, patients having knee OA with a flexion deformity compensate their posture by increasing the lumbar lordosis, if the lumbar spine lost its ability to compensate for the knee deformity, this could aggravate low back pain and enhance further lumbar spine instability and spondylosis . In addition, the persistence of coexisting lumbar spine symptoms after TKA might adversely affect postoperative outcomes in terms of pain and function, even after successful TKA . Chang et al., studied the prevalence and severity of coexisting lumbar spondylosis in terms of radiographic lumbar spine degeneration and lumbar spine symptoms in patients with advanced knee OA undergoing TKR, in their study, 51% of patients undergoing TKR had at least one moderate to severe lumbar spine symptom, and patients with severe radicular pain on the activity before the TKR was likely to demonstrate poor knee function 2 years post-TKR . This is why lumbar spine pathologies should be fully investigated in patients coming for TKR.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date June 2024
Est. primary completion date May 2024
Accepts healthy volunteers
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: - primary end-stage knee osteoarthritis. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
x-ray
plain radiographs of lower limb anteroposterior and lateral views , lumbar spine plain radiographs (anteroposterior, lateral, lateral in flexion and lateral in extension views )

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Change in characters of low back pain over the postoperative period. Recording the changes of the backpain after Total knee replacement using Oswestry disability index scale which is 0 is the minimum value and 100 is the maximum value which in turn presents with the worst outcome 6 months follow up
Secondary Spine radiological features. Recording the radiological features of Lumber spine through plain xrays of to evaluate the presence of Spondylolisthesis Baseline
Secondary Knee radiological and alignment features. Recording the radiological features of knee through plain xrays of to measure the hip knee ankle angle Baseline
See also
  Status Clinical Trial Phase
Recruiting NCT05527145 - Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial N/A
Not yet recruiting NCT05480267 - A RCT of UBE vs. MIS-TLIF in Lumbar Spondylolisthesis N/A
Not yet recruiting NCT03271060 - Comparative Study Between Posterior Lumbar Interbody Fusion(PLIF) and Intertransverse Process Fusion in Treatment of Spodylolithesis N/A
Terminated NCT03570801 - SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion N/A
Recruiting NCT05023733 - Clinical and Radiographic Outcomes of TLIF w/3D Printed Cellular Implant
Recruiting NCT02972190 - Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis N/A
Completed NCT04520334 - A Zhineng Qigong Intervention for Patients With Chronic Low Back Pain and/or Leg Pain N/A
Recruiting NCT05405374 - OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study N/A
Completed NCT03327298 - Free Hand Lumbar Pedicular Screw Fixation N/A
Recruiting NCT06154005 - OsteoAdapt SP Advanced Bone Graft Feasibility Study - Transforaminal Interbody Lumbar Fusion Phase 1/Phase 2
Not yet recruiting NCT06255366 - Analysis of the Clinical Efficacy of Intravenous Application of Hemostatic Drugs in Improving the Clarity of Vision Under Endoscope, Perioperative Bleeding Volume and Anti-inflammatory Effect of Spinal Endoscopic Lumbar Fusion Phase 4
Active, not recruiting NCT03733626 - Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease N/A
Active, not recruiting NCT05993195 - Re-operation Rates of Concorde Bullet Device Versus Conduit Titanium Interbody Graft for Lumbar Fusion
Active, not recruiting NCT03879447 - Effectiveness and Safety of Korean Medicine for Low Back Pain or Sciatica Due to Lumbar Stenosis/Spondylolisthesis
Not yet recruiting NCT05691062 - Titanium vs. PEEK Fusion Devices in 1 Level TLIF Phase 4
Completed NCT05345249 - Erector Spinae Plane Block as Pain Management After Lumbar Fusion Surgery Phase 4
Completed NCT05959343 - Enhanced Recovery After Surgery in Oblique Lumbar Interbody Fusion N/A
Recruiting NCT03745040 - Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion Phase 4
Recruiting NCT03969602 - Cognitive Behavioral Therapy (CBT) After Lumbar Spinal Fusion in Patients With High Pain Catastrophizing N/A
Completed NCT04886557 - Retrospective Image Analysis of Degenerative Lumbar Disease Patients