Comparison of Restricted Versus Unrestricted Kinematic Alignment in 1ry TKA
NCT ID: NCT06726993
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2025-02-01
2027-06-01
Brief Summary
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The definitive treatment for knee joint degeneration is total knee arthroplasty.
Detailed Description
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Consequently, the conventional mechanical alignment technique has been recently challenged by a new alternative technique, namely unrestricted kinematic alignment proposed by Howell, as a possible solution to the high dissatisfaction following total knee arthroplasty, aiming at reproducing the constitutional tibiofemoral tridimensional alignment and knee laxity. It is almost a pure bone procedure with only exceptional collateral ligament release, which has been shown to reliably position knee components.
The restricted kinematic alignment protocol suggested by Vendittoli has been developed as an alternative to the unrestricted kinematic alignment for patients with an outlier or atypical knee anatomy. The restricted kinematic alignment is founded on five principles: hip-knee-ankle angle should be maintained within ± 3° postoperatively; a limitation to a maximum of 5° for lateral distal femoral angle and medial proximal tibial angle may be considered; restoration of collateral ligament balance should be achieved without the gap balancing technique; native femoral anatomy preservation is suggested over tibial one to maintain knee biomechanics; resurface resection must be accomplished on the unworn side with a thickness equivalent to the width of the implant;cut fine-tuning may be sought at the worn side.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Unrestricted kinematic alignment
reproducing the constitutional tibiofemoral tridimensional alignment and knee laxity. It is almost a pure bone procedure with only exceptional collateral ligament release, which has been shown to reliably position knee components.
Total knee arthroplasty
Total knee arthroplasty (TKA) is a common orthopaedic surgery that involves replacing the articular surfaces (femoral condyles and tibial plateau) of the knee joint with smooth metal and highly cross-linked polyethylene plastic
Restricted kinematic alignment
reproducing patient's constitutional knee anatomy within a safe range while avoiding extreme or pathological anatomies that have been demonstrated to exist.
Total knee arthroplasty
Total knee arthroplasty (TKA) is a common orthopaedic surgery that involves replacing the articular surfaces (femoral condyles and tibial plateau) of the knee joint with smooth metal and highly cross-linked polyethylene plastic
Interventions
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Total knee arthroplasty
Total knee arthroplasty (TKA) is a common orthopaedic surgery that involves replacing the articular surfaces (femoral condyles and tibial plateau) of the knee joint with smooth metal and highly cross-linked polyethylene plastic
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Malalignment more than 10° or less than 3° varus of knee joint.
3. Ligamentous laxity of the affected knee (medial or lateral collateral ligaments)
4. any tumors or secondary neoplasia diseases
5. Knee joint infection
6. severe cardiopulmonary dysfunction.
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Sohibe Abdulazeem Ghietah Hussein
Doctor
Principal Investigators
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Sohibe A Ghietah, Specialist
Role: PRINCIPAL_INVESTIGATOR
Assiut University
Central Contacts
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References
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Howell SM HM. Kinematic alignment in TKA: definition, surgical technique, and challenging cases.. Orthopedic Knowledge Online. 2012; 10(7).
Risitano S, Cacciola G, Sabatini L, Capella M, Bosco F, Giustra F, Masse A, Vaishya R. Restricted kinematic alignment in primary total knee arthroplasty: A systematic review of radiographic and clinical data. J Orthop. 2022 Jul 2;33:37-43. doi: 10.1016/j.jor.2022.06.014. eCollection 2022 Sep-Oct.
Albishi W, AbuDujain NM, Arafah O, Alshaygy IS, Aldosari ZA, Alhuqbani MN, Alangari SM. Cross-cultural adaptation, validity and reliability of the Arabic version of the Forgotten Joint Score for knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2023 Oct;31(10):4312-4318. doi: 10.1007/s00167-023-07484-y. Epub 2023 Jun 17.
Behrend H, Giesinger K, Giesinger JM, Kuster MS. The "forgotten joint" as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty. 2012 Mar;27(3):430-436.e1. doi: 10.1016/j.arth.2011.06.035. Epub 2011 Oct 13.
Almangoush A, Herrington L, Attia I, Jones R, Aldawoudy A, Abdul Aziz A, Waley A. Cross-cultural adaptation, reliability, internal consistency and validation of the Arabic version of the knee injury and osteoarthritis outcome score (KOOS) for Egyptian people with knee injuries. Osteoarthritis Cartilage. 2013 Dec;21(12):1855-64. doi: 10.1016/j.joca.2013.09.010. Epub 2013 Oct 2.
Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.
Ahmed KM, Said HG, Ramadan EKA, Abd El-Radi M, El-Assal MA. Arabic translation and validation of three knee scores, Lysholm Knee Score (LKS), Oxford Knee Score (OKS), and International Knee Documentation Committee Subjective Knee Form (IKDC). SICOT J. 2019;5:6. doi: 10.1051/sicotj/2018054. Epub 2019 Mar 8.
Dawson J, Fitzpatrick R, Murray D, Carr A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg Br. 1998 Jan;80(1):63-9. doi: 10.1302/0301-620x.80b1.7859.
MacDessi SJ, Griffiths-Jones W, Harris IA, Bellemans J, Chen DB. Coronal Plane Alignment of the Knee (CPAK) classification. Bone Joint J. 2021 Feb;103-B(2):329-337. doi: 10.1302/0301-620X.103B2.BJJ-2020-1050.R1.
Vendittoli PA, Martinov S, Blakeney WG. Restricted Kinematic Alignment, the Fundamentals, and Clinical Applications. Front Surg. 2021 Jul 20;8:697020. doi: 10.3389/fsurg.2021.697020. eCollection 2021.
Hutt JR, LeBlanc MA, Masse V, Lavigne M, Vendittoli PA. Kinematic TKA using navigation: Surgical technique and initial results. Orthop Traumatol Surg Res. 2016 Feb;102(1):99-104. doi: 10.1016/j.otsr.2015.11.010. Epub 2016 Jan 6.
Ranawat AS, Ranawat CS, Elkus M, Rasquinha VJ, Rossi R, Babhulkar S. Total knee arthroplasty for severe valgus deformity. J Bone Joint Surg Am. 2005 Sep;87 Suppl 1(Pt 2):271-84. doi: 10.2106/JBJS.E.00308.
Howell SM, Howell SJ, Hull ML. Assessment of the radii of the medial and lateral femoral condyles in varus and valgus knees with osteoarthritis. J Bone Joint Surg Am. 2010 Jan;92(1):98-104. doi: 10.2106/JBJS.H.01566.
Bellemans J, Colyn W, Vandenneucker H, Victor J. The Chitranjan Ranawat award: is neutral mechanical alignment normal for all patients? The concept of constitutional varus. Clin Orthop Relat Res. 2012 Jan;470(1):45-53. doi: 10.1007/s11999-011-1936-5.
Nam D, Nunley RM, Barrack RL. Patient dissatisfaction following total knee replacement: a growing concern? Bone Joint J. 2014 Nov;96-B(11 Supple A):96-100. doi: 10.1302/0301-620X.96B11.34152.
Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
Collins M, Lavigne M, Girard J, Vendittoli PA. Joint perception after hip or knee replacement surgery. Orthop Traumatol Surg Res. 2012 May;98(3):275-80. doi: 10.1016/j.otsr.2011.08.021. Epub 2012 Mar 28.
Blakeney W, Clement J, Desmeules F, Hagemeister N, Riviere C, Vendittoli PA. Kinematic alignment in total knee arthroplasty better reproduces normal gait than mechanical alignment. Knee Surg Sports Traumatol Arthrosc. 2019 May;27(5):1410-1417. doi: 10.1007/s00167-018-5174-1. Epub 2018 Oct 1.
Almaawi AM, Hutt JRB, Masse V, Lavigne M, Vendittoli PA. The Impact of Mechanical and Restricted Kinematic Alignment on Knee Anatomy in Total Knee Arthroplasty. J Arthroplasty. 2017 Jul;32(7):2133-2140. doi: 10.1016/j.arth.2017.02.028. Epub 2017 Feb 20.
Cherian JJ, Kapadia BH, Banerjee S, Jauregui JJ, Issa K, Mont MA. Mechanical, Anatomical, and Kinematic Axis in TKA: Concepts and Practical Applications. Curr Rev Musculoskelet Med. 2014 Jun;7(2):89-95. doi: 10.1007/s12178-014-9218-y.
Riviere C, Iranpour F, Harris S, Auvinet E, Aframian A, Chabrand P, Cobb J. The kinematic alignment technique for TKA reliably aligns the femoral component with the cylindrical axis. Orthop Traumatol Surg Res. 2017 Nov;103(7):1069-1073. doi: 10.1016/j.otsr.2017.06.016. Epub 2017 Sep 1.
Other Identifiers
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04-2024-100320
Identifier Type: -
Identifier Source: org_study_id