Biplanar PSI Slope-reducing MOWHTO With Tibial Tuberosity Serving as Hinge Axis: Cadaveric Study

NCT05448742 | Unknown

• 1 other identifier: 1-pro-ar-2022
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Six cadaveric lower limbs will have PSI slope-reducing MOWHTO performed on and accuraccy of biplanar correction will be assessed.

Conditions

Knee Disease; Knee Osteoarthritis; Knee Injuries and Disorders

Outcome Measures

Primary Outcomes (4)

• Feasibility of the 3D PSI device to achieve desired Medial Proximal Tibial Angle

  Feasibility of the 3D PSI device to achieve desired Medial Proximal Tibial Angle - measurement of preop, postop and amount of desired and performed correction on cadavers (not clinical data, measurement on cadavers)

  Procedures will be perfomred on cadaveric limbs on 22th June 2022 and analyzed within 6 weeks

• Feasibility of the 3D PSI device to achieve desired Medial Proximal Tibial Slope

  Feasibility of the 3D PSI device to achieve desired Medial Proximal Tibial Slope - measurement of preop, postop and amount of desired and performed correction on cadavers (not clinical data, measurement on cadavers)

  Procedures will be perfomred on cadaveric limbs on 22th June 2022 and analyzed within 6 weeks

• Feasibility of the 3D PSI device to achieve desired Lateral Proximal Tibial Slope

  Feasibility of the 3D PSI device to achieve desired Lateral Proximal Tibial Slope - measurement of preop, postop and amount of desired and performed correction on cadavers (not clinical data, measurement on cadavers)

  Procedures will be perfomred on cadaveric limbs on 22th June 2022 and analyzed within 6 weeks

• Feasibility of the 3D PSI device to achieve desired anatomical FemoroTibial Angle

  Feasibility of the 3D PSI device to achieve desired anatomical FemoroTibial Angle - measurement of preop, postop and amount of desired and performed correction on cadavers (not clinical data, measurement on cadavers)

  Procedures will be perfomred on cadaveric limbs on 22th June 2022 and analyzed within 6 weeks

Secondary Outcomes (4)

• Feasibility of the 3D PSI device to avoid change of anatomical Insall-Salvati Index

  Procedures will be perfomred on cadaveric limbs on 22th June 2022 and analyzed within 6 weeks

• Feasibility of the 3D PSI device to avoid change of anatomical Blackburn-Peel Index

  Procedures will be perfomred on cadaveric limbs on 22th June 2022 and analyzed within 6 weeks

• Feasibility of the 3D PSI device to avoid change of anatomical Caton-Deschamps Index

  Procedures will be perfomred on cadaveric limbs on 22th June 2022 and analyzed within 6 weeks

• Feasibility of the 3D PSI device to avoid intraoperative fractures

  Procedures will be perfomred on cadaveric limbs on 22th June 2022 and analyzed within 6 weeks

Study Arms (1)

Main arm of the study

EXPERIMENTAL

Six cadaveric lower limbs will have biplanar PSI slope-reducing MOWHTO performed on and accuracy of biplanar correction will be assessed.

Device: Biplanar PSI slope-reducing MOWHTO.

Interventions

Biplanar PSI slope-reducing MOWHTO. DEVICE

High tibial osteotomy (HTO) is a widely performed procedure in case of varus knee with medial compartment osteoarthritis (OA), with medial-opening wedge version performed more often than lateral-closing wedge one. While in most cases the goal of medial-opening wedge HTO (MOWHTO) is isolated correction of coronal limb alignment, intentional or unintentional increase of posterior tibial slope (PTS) after MOWHTO can occur, however its extent is usually limited and depends on accurate hinge axis placement. One of the ideas developed to improve accuracy of hinge axis placement and accuracy of biplanar correction are Patient-Specific Instruments (PSI). Our intervention is novel, biplanar, medial-opening wedge, posterior tibial slope-reducing high tibial osteotomy aided by PSI, with tibial tuberosity serving as hinge axis.

Main arm of the study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Six fresh-frozen cadaveric lower limbs with 2/3 distal of femoral shaft and full-length leg with ankle and feet will be included in the study

Sponsors & Collaborators

• Artromedical Konrad Malinowski Clinic: lead

Study Sites (1)

Artromedical Orthopaedic Clinic

Bełchatów, Poland

Location

Related Publications (28)

• Bin SI, Kim HJ, Ahn HS, Rim DS, Lee DH. Changes in Patellar Height After Opening Wedge and Closing Wedge High Tibial Osteotomy: A Meta-analysis. Arthroscopy. 2016 Nov;32(11):2393-2400. doi: 10.1016/j.arthro.2016.06.012. Epub 2016 Aug 25.

  PMID: 27570171 BACKGROUND

• Calek AK, Hochreiter B, Hess S, Amsler F, Leclerq V, Hirschmann MT, Behrend H. High inter- and intraindividual differences in medial and lateral posterior tibial slope are not reproduced accurately by conventional TKA alignment techniques. Knee Surg Sports Traumatol Arthrosc. 2022 Mar;30(3):882-889. doi: 10.1007/s00167-021-06477-z. Epub 2021 Feb 6.

  PMID: 33547913 BACKGROUND

• Dejour D, Saffarini M, Demey G, Baverel L. Tibial slope correction combined with second revision ACL produces good knee stability and prevents graft rupture. Knee Surg Sports Traumatol Arthrosc. 2015 Oct;23(10):2846-52. doi: 10.1007/s00167-015-3758-6. Epub 2015 Aug 23.

  PMID: 26298711 BACKGROUND

• Dexel J, Fritzsche H, Beyer F, Harman MK, Lutzner J. Open-wedge high tibial osteotomy: incidence of lateral cortex fractures and influence of fixation device on osteotomy healing. Knee Surg Sports Traumatol Arthrosc. 2017 Mar;25(3):832-837. doi: 10.1007/s00167-015-3730-5. Epub 2015 Aug 8.

  PMID: 26254088 BACKGROUND

• Donnez M, Ollivier M, Munier M, Berton P, Podgorski JP, Chabrand P, Parratte S. Are three-dimensional patient-specific cutting guides for open wedge high tibial osteotomy accurate? An in vitro study. J Orthop Surg Res. 2018 Jul 9;13(1):171. doi: 10.1186/s13018-018-0872-4.

  PMID: 29986731 BACKGROUND

• Eliasberg CD, Hancock KJ, Swartwout E, Robichaud H, Ranawat AS. The Ideal Hinge Axis Position to Reduce Tibial Slope in Opening-Wedge High Tibial Osteotomy Includes Proximalization-Extension and Internal Rotation. Arthroscopy. 2021 May;37(5):1577-1584. doi: 10.1016/j.arthro.2020.12.203. Epub 2020 Dec 24.

  PMID: 33359158 BACKGROUND

• Gooi SG, Chan CXY, Tan MKL, Lim AKS, Satkunanantham K, Hui JHP. Patella Height Changes Post High Tibial Osteotomy. Indian J Orthop. 2017 Sep-Oct;51(5):545-551. doi: 10.4103/ortho.IJOrtho_214_17.

  PMID: 28966378 BACKGROUND

• Goutallier D, Delepine G, Debeyre J. [The patello-femoral joint in osteoarthritis of the knee with genu varum (author's transl)]. Rev Chir Orthop Reparatrice Appar Mot. 1979 Jan-Feb;65(1):25-31. French.

  PMID: 156384 BACKGROUND

• Hankemeier S, Hufner T, Wang G, Kendoff D, Zeichen J, Zheng G, Krettek C. Navigated open-wedge high tibial osteotomy: advantages and disadvantages compared to the conventional technique in a cadaver study. Knee Surg Sports Traumatol Arthrosc. 2006 Oct;14(10):917-21. doi: 10.1007/s00167-006-0035-8. Epub 2006 Feb 24.

  PMID: 16501952 BACKGROUND

• Kesmezacar H, Erginer R, Ogut T, Seyahi A, Babacan M, Tenekecioglu Y. Evaluation of patellar height and measurement methods after valgus high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2005 Oct;13(7):539-44. doi: 10.1007/s00167-004-0572-y. Epub 2005 Jan 8.

  PMID: 15645214 BACKGROUND

• Kim HJ, Park J, Park KH, Park IH, Jang JA, Shin JY, Kyung HS. Evaluation of Accuracy of a Three-Dimensional Printed Model in Open-Wedge High Tibial Osteotomy. J Knee Surg. 2019 Sep;32(9):841-846. doi: 10.1055/s-0038-1669901. Epub 2018 Sep 6.

  PMID: 30189435 BACKGROUND

• Klek M, Dhawan A. The Role of High Tibial Osteotomy in ACL Reconstruction in Knees with Coronal and Sagittal Plane Deformity. Curr Rev Musculoskelet Med. 2019 Dec;12(4):466-471. doi: 10.1007/s12178-019-09589-9.

  PMID: 31760623 BACKGROUND

• Kwun JD, Kim HJ, Park J, Park IH, Kyung HS. Open wedge high tibial osteotomy using three-dimensional printed models: Experimental analysis using porcine bone. Knee. 2017 Jan;24(1):16-22. doi: 10.1016/j.knee.2016.09.026. Epub 2016 Nov 19.

  PMID: 27876267 BACKGROUND

• Lee BH, Ha CW, Moon SW, Chang M, Kim HY, Park SH, Wang JH. Three-dimensional relationships between secondary changes and selective osteotomy parameters for biplane medial open-wedge high tibial osteotomy. Knee. 2017 Mar;24(2):362-371. doi: 10.1016/j.knee.2016.11.010. Epub 2017 Feb 4.

  PMID: 28169100 BACKGROUND

• Lee SJ, Kim JH, Baek E, Ryu HS, Han D, Choi W. Incidence and Factors Affecting the Occurrence of Lateral Hinge Fracture After Medial Opening-Wedge High Tibial Osteotomy. Orthop J Sports Med. 2021 Oct 8;9(10):23259671211035372. doi: 10.1177/23259671211035372. eCollection 2021 Oct.

  PMID: 34646897 BACKGROUND

• Meier M, Janssen D, Koeck FX, Thienpont E, Beckmann J, Best R. Variations in medial and lateral slope and medial proximal tibial angle. Knee Surg Sports Traumatol Arthrosc. 2021 Mar;29(3):939-946. doi: 10.1007/s00167-020-06052-y. Epub 2020 May 10.

  PMID: 32390118 BACKGROUND

• Miao Z, Li S, Luo D, Lu Q, Liu P. The validity and accuracy of 3D-printed patient-specific instruments for high tibial osteotomy: a cadaveric study. J Orthop Surg Res. 2022 Jan 29;17(1):62. doi: 10.1186/s13018-022-02956-2.

  PMID: 35093132 BACKGROUND

• Moon SW, Park SH, Lee BH, Oh M, Chang M, Ahn JH, Wang JH. The Effect of Hinge Position on Posterior Tibial Slope in Medial Open-Wedge High Tibial Osteotomy. Arthroscopy. 2015 Jun;31(6):1128-33. doi: 10.1016/j.arthro.2015.01.009. Epub 2015 Mar 3.

  PMID: 25744929 BACKGROUND

• Neyret P, Zuppi G, Selmi TA (2000) Tibial deflexion osteotomy. Oper Tech Sports Med 8:61-66

  BACKGROUND

• Nha KW, Kim HJ, Ahn HS, Lee DH. Change in Posterior Tibial Slope After Open-Wedge and Closed-Wedge High Tibial Osteotomy: A Meta-analysis. Am J Sports Med. 2016 Nov;44(11):3006-3013. doi: 10.1177/0363546515626172. Epub 2016 Feb 12.

  PMID: 26872893 BACKGROUND

• Noyes FR, Goebel SX, West J. Opening wedge tibial osteotomy: the 3-triangle method to correct axial alignment and tibial slope. Am J Sports Med. 2005 Mar;33(3):378-87. doi: 10.1177/0363546504269034.

  PMID: 15716253 BACKGROUND

• Song KY, Koh IJ, Kim MS, Choi NY, Jeong JH, In Y. Early experience of lateral hinge fracture during medial opening-wedge high tibial osteotomy: incidence and clinical outcomes. Arch Orthop Trauma Surg. 2020 Feb;140(2):161-169. doi: 10.1007/s00402-019-03237-0. Epub 2019 Jul 4.

  PMID: 31273455 BACKGROUND

• Teng Y, Mizu-Uchi H, Xia Y, Akasaki Y, Akiyama T, Kawahara S, Nakashima Y. Axial But Not Sagittal Hinge Axis Affects Posterior Tibial Slope in Medial Open-Wedge High Tibial Osteotomy: A 3-Dimensional Surgical Simulation Study. Arthroscopy. 2021 Jul;37(7):2191-2201. doi: 10.1016/j.arthro.2021.01.063. Epub 2021 Feb 11.

  PMID: 33581296 BACKGROUND

• Tischer T, Paul J, Pape D, Hirschmann MT, Imhoff AB, Hinterwimmer S, Feucht MJ. The Impact of Osseous Malalignment and Realignment Procedures in Knee Ligament Surgery: A Systematic Review of the Clinical Evidence. Orthop J Sports Med. 2017 Mar 27;5(3):2325967117697287. doi: 10.1177/2325967117697287. eCollection 2017 Mar.

  PMID: 28451605 BACKGROUND

• Vadhera AS, Knapik DM, Gursoy S, Farivar D, Perry AK, Cole BJ, Chahla J. Current Concepts in Anterior Tibial Closing Wedge Osteotomies for Anterior Cruciate Ligament Deficient Knees. Curr Rev Musculoskelet Med. 2021 Dec;14(6):485-492. doi: 10.1007/s12178-021-09729-0. Epub 2021 Dec 15.

  PMID: 34907514 BACKGROUND

• Won HH, Chang CB, Je MS, Chang MJ, Kim TK. Coronal limb alignment and indications for high tibial osteotomy in patients undergoing revision ACL reconstruction. Clin Orthop Relat Res. 2013 Nov;471(11):3504-11. doi: 10.1007/s11999-013-3185-2. Epub 2013 Jul 23.

  PMID: 23877556 BACKGROUND

• Wu CC. Is clinical measurement of anatomic axis of the femur adequate? Acta Orthop. 2017 Aug;88(4):407-410. doi: 10.1080/17453674.2017.1304788. Epub 2017 Mar 23.

  PMID: 28333575 BACKGROUND

• Yang JC, Chen CF, Luo CA, Chang MC, Lee OK, Huang Y, Lin SC. Clinical Experience Using a 3D-Printed Patient-Specific Instrument for Medial Opening Wedge High Tibial Osteotomy. Biomed Res Int. 2018 May 8;2018:9246529. doi: 10.1155/2018/9246529. eCollection 2018.

  PMID: 29854810 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Knee Injuries; Disease

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Konrad Malinowski, MD PhD

  Artromedical Orthopaedic Clinic, Bełchatów, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Konrad Malinowski MD, Director of Artromedical Konrad Malinowski Clinic and Principal Investigator

Model Details: Six cadaveric lower limbs will have biplanar PSI slope-reducing MOWHTO performed on and accuracy of biplanar correction will be assessed.

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: July 7, 2022
• Study Start: June 22, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)