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Lumbar SpondylolisthesisNCT05464134

Incidence of Lumbar Spondylolisthesis in Patients Candidate for TKR

An observational study of Lumbar Spondylolisthesis, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Lumbar Spondylolisthesis
What is being tested?
x-ray
Type of treatment
Surgery or procedure
How many people
60 participants
Where
No sites listed yet
Study dates
May 2023to Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • primary end-stage knee osteoarthritis.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Mario Sameh Wadie, physician contact

+201271972023

mariowadeeeeee3@gmail.com

About this study

Official title: Incidence of Lumbar Spondylolisthesis in Patients Candidate for Total Knee Replacement

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.

Read the detailed 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.

Being tested
x-ray
Medical subject headings
Spondylolisthesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • x-rayRadiation

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of lumbar spine spondylolisthesis.

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

    Measured: Baseline

  2. 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

    Measured: Baseline

  3. 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

    Measured: Baseline

Secondary outcomes (3)

  1. 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

    Measured: 6 months follow up

  2. Spine radiological features.

    Recording the radiological features of Lumber spine through plain xrays of to evaluate the presence of Spondylolisthesis

    Measured: Baseline

  3. Knee radiological and alignment features.

    Recording the radiological features of knee through plain xrays of to measure the hip knee ankle angle

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2022
  2. Study startMay 2023 (estimated)
  3. Primary completionMay 2024 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05464134
Sponsor's protocol ID
Lumbar Spondylolisthesis & TKR
Status last verified
May 2023
First submitted
27 May 2022
Last updated
19 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 29983663

  • 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.

    PubMed 30522138

  • 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.

    PubMed 33355851

  • 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.

    PubMed 24065173

Questions about this trial

What is this clinical trial studying?

An observational study of Lumbar Spondylolisthesis, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mario Sameh Wadie, physician (+201271972023, mariowadeeeeee3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of lumbar spine spondylolisthesis. (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05464134, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.

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