Clinical trial NCT05464134: Incidence of Lumbar Spondylolisthesis in Patients Candidate for TKR
Official title: Incidence of Lumbar Spondylolisthesis in Patients Candidate for Total Knee Replacement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lumbar Spondylolisthesis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of lumbar spine spondylolisthesis.
timeFrame: Baseline
measure: Severity of lumbar spine spondylolisthesis.
timeFrame: Baseline
measure: occurence of lumbar spine spondylolishtesis Occurrence of lumbar spine spondylolisthesis
timeFrame: Baseline
Secondary outcomes:
measure: Change in characters of low back pain over the postoperative period.
timeFrame: 6 months follow up
measure: Spine radiological features.
timeFrame: Baseline
measure: Knee radiological and alignment features.
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
citation: 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.