Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:26 PM
Study NCT ID:
NCT05464134
Status:
UNKNOWN
Last Update Posted:
2023-05-19
First Post:
2022-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Lumbar Spondylolisthesis in Patients Candidate for TKR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013168', 'term': 'Spondylolisthesis'}], 'ancestors': [{'id': 'D013169', 'term': 'Spondylolysis'}, {'id': 'D055009', 'term': 'Spondylosis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-18', 'studyFirstSubmitDate': '2022-05-27', 'studyFirstSubmitQcDate': '2022-07-15', 'lastUpdatePostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of lumbar spine spondylolisthesis.', 'timeFrame': 'Baseline', 'description': 'showing the incidence and occurrence of Lumbar Spondylolisthesis in patients with severe knee Osteoarthritis which needs Total knee replacement'}, {'measure': 'Severity of lumbar spine spondylolisthesis.', 'timeFrame': 'Baseline', 'description': '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'}, {'measure': 'occurence of lumbar spine spondylolishtesis Occurrence of lumbar spine spondylolisthesis', 'timeFrame': 'Baseline', 'description': 'Showing the occurrence of lumbar spine spondylolisthesis in patients with severe osteoarthritis which needs total knee replacement'}], 'secondaryOutcomes': [{'measure': 'Change in characters of low back pain over the postoperative period.', 'timeFrame': '6 months follow up', 'description': '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'}, {'measure': 'Spine radiological features.', 'timeFrame': 'Baseline', 'description': 'Recording the radiological features of Lumber spine through plain xrays of to evaluate the presence of Spondylolisthesis'}, {'measure': 'Knee radiological and alignment features.', 'timeFrame': 'Baseline', 'description': 'Recording the radiological features of knee through plain xrays of to measure the hip knee ankle angle'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Spondylolisthesis']}, 'referencesModule': {'references': [{'pmid': '29983663', 'type': 'BACKGROUND', '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.'}, {'pmid': '30522138', 'type': 'BACKGROUND', '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.'}, {'pmid': '33355851', 'type': 'BACKGROUND', '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.'}, {'pmid': '24065173', 'type': 'BACKGROUND', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.nejm.org/doi/full/10.1056/NEJMoa2100990', 'label': 'Decompression with or without fusion in degenerative lumbar spondylolisthesis'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSpondylolisthesis 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 .\n\nIn 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 .\n\nChang 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary end-stage knee osteoarthritis.\n\nExclusion Criteria:\n\n* secondary inflammatory knee osteoarthritis.\n* post traumatic knee osteoarthritis.\n* patients with active infection.\n* patients with poor general condition.\n* patients who had previous spinal fixation or fusion surgery.'}, 'identificationModule': {'nctId': 'NCT05464134', 'briefTitle': 'Incidence of Lumbar Spondylolisthesis in Patients Candidate for TKR', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Incidence of Lumbar Spondylolisthesis in Patients Candidate for Total Knee Replacement', 'orgStudyIdInfo': {'id': 'Lumbar Spondylolisthesis & TKR'}}, 'armsInterventionsModule': {'interventions': [{'name': 'x-ray', 'type': 'RADIATION', 'description': 'plain radiographs of lower limb anteroposterior and lateral views , lumbar spine plain radiographs (anteroposterior, lateral, lateral in flexion and lateral in extension views )'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mario Sameh Wadie, physician', 'role': 'CONTACT', 'email': 'mariowadeeeeee3@gmail.com', 'phone': '+201271972023'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mario Sameh Wadie Narouz', 'investigatorAffiliation': 'Assiut University'}}}}