Comparison of Pinless Navigation and Conventional Method in Total Knee Arthroplasty

NCT04235283 | Unknown FDA Device

• 1 other identifier: CMRPG8J0311
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to conduct a prospective randomized clinical trial to compare the accuracy of prosthesis, radiographic alignment, total blood loss, the risk of venous thromboembolism between pinless-navigated total knee arthroplasty (TKA) and traditional TKA.

Conditions

Osteoarthritis, Knee

Keywords

Total knee arthroplasty; pinless; navigation; alignment; minimal invasive

Outcome Measures

Primary Outcomes (5)

• Radiographic outcome: the mechanical alignment (MA)

  The mechanical alignment (MA): an angle between the mechanical axis of the femur and the tibial shaft axis

  Three months after operation

• Radiographic outcome: anatomic alignment (AA)

  The anatomic alignment (AA): an angle between the axis of the femoral shaft and the tibial shaft axis

  Three months after operation

• Radiographic outcome: femoral bowing angle (FBA)

  The femoral bowing angle (FBA): the angle between the distal and proximal femoral anatomical axes

  Three months after operation

• Radiographic outcome: coronal femoral-component angle (CFA)

  Tthe angle between the femoral mechanical axis and the femoral component

  Three months after operation

• Radiographic outcome: coronal tibia-component angle (CTA)

  The angle between the tibial shaft axis and the tibial component

  Three months after operation

Secondary Outcomes (6)

• Total Blood Loss

  Postoperative Day 3

• Blood transfusion rate

  Three months after operation

• Operating Time

  After the procedure is done

• Surgical wound length

  After the procedure is done

• Wound complications

  Three months after operation

Study Arms (2)

Group I

EXPERIMENTAL

Primary total knee replacement by pinless navigation and minimally invasive technique

Device: Primary total knee replacement by pinless navigation (Orthomap Express,Stryker, Michigan)

Group II

ACTIVE COMPARATOR

Primary total knee replacement by traditional jig and minimally invasive technique

Procedure: Primary total knee replacement by traditional jig and minimally invasive technique

Interventions

Primary total knee replacement by pinless navigation (Orthomap Express,Stryker, Michigan) DEVICE

The varus/valgus, extension/flexion, thickness of distal cut of femur was determined and done by pinless navigation system. After cutting, the instant information of resection level can show on the display screen. If the alignment is satisfying, the anterior/posterior femoral cut, chamfer cut and box resection were done by conventional jig

Group I

Primary total knee replacement by traditional jig and minimally invasive technique PROCEDURE

The femoral alignment was determined by intramedullary guide. The femoral alignment jig was set to 5-7 degree valgus dependent on the preoperative radiograph. A bone plug is impacted into the entry hole of femoral medullary canal before prosthesis placement.

Group II

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with osteoarthritis of the knee secondary to degeneration, inflammatory arthritis, gouty arthritis, posttraumatic arthritis, and undergoing primary unilateral minimally invasive TKA
• Age \> 50 years and \< 90 years
• Failure of medical treatment or rehabilitation.
• Hemoglobin \> 11g/dl,
• No use of non-steroid anti-inflammatory agent one week before operation

You may not qualify if:

• Preoperative Hemoglobin \<11 g/dl
• History of infection or intraarticular fracture of the affective knee
• Renal function deficiency (GFR \<30 ml/min/1.73m2)
• Elevated liver enzyme (AST/ALT level are more than twice normal range) , history of liver cirrhosis, impaired liver function(elevated total bilirubin level) and coagulopathy (including long-term use anticoagulant)
• History of deep vein thrombosis, ischemic heart disease, cardiac arrythmia requiring life-long anti-coagulants, or stroke
• Contraindications of tranexamic acid, rivaroxaban, or the excipients
• Allergy to tranexamic acid, rivaroxaban, or the excipients
• Coagulopathy or bleeding tendency caused by organ dysfunction, such as cirrhosis, bone marrow suppression etc.
• Patient who have active bleeding disorder, such as intracranial hemorrhage, upper GI bleeding, hematuria

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Related Publications (18)

• Zhang Z, Zhu W, Gu B, Zhu L, Chen C. Mini-midvastus versus mini-medial parapatellar approach in total knee arthroplasty: a prospective, randomized study. Arch Orthop Trauma Surg. 2013 Mar;133(3):389-95. doi: 10.1007/s00402-012-1645-x. Epub 2012 Dec 11.

  PMID: 23229457 BACKGROUND

• Nestor BJ, Toulson CE, Backus SI, Lyman SL, Foote KL, Windsor RE. Mini-midvastus vs standard medial parapatellar approach: a prospective, randomized, double-blinded study in patients undergoing bilateral total knee arthroplasty. J Arthroplasty. 2010 Sep;25(6 Suppl):5-11, 11.e1. doi: 10.1016/j.arth.2010.04.003. Epub 2010 Jun 11.

  PMID: 20541889 BACKGROUND

• Dalury DF, Dennis DA. Mini-incision total knee arthroplasty can increase risk of component malalignment. Clin Orthop Relat Res. 2005 Nov;440:77-81. doi: 10.1097/01.blo.0000185757.17401.7b.

  PMID: 16239787 BACKGROUND

• Berend ME, Ritter MA, Meding JB, Faris PM, Keating EM, Redelman R, Faris GW, Davis KE. Tibial component failure mechanisms in total knee arthroplasty. Clin Orthop Relat Res. 2004 Nov;(428):26-34. doi: 10.1097/01.blo.0000148578.22729.0e.

  PMID: 15534515 BACKGROUND

• King J, Stamper DL, Schaad DC, Leopold SS. Minimally invasive total knee arthroplasty compared with traditional total knee arthroplasty. Assessment of the learning curve and the postoperative recuperative period. J Bone Joint Surg Am. 2007 Jul;89(7):1497-503. doi: 10.2106/JBJS.F.00867.

  PMID: 17606788 BACKGROUND

• Zhang Z, Gu B, Zhu W, Zhu L, Li Q, Du Y. Minimal invasive and computer-assisted total knee replacement compared with the minimal invasive technique: a prospective, randomized trial with short-term outcomes. Arch Orthop Trauma Surg. 2014 Jan;134(1):65-71. doi: 10.1007/s00402-013-1879-2. Epub 2013 Nov 8.

  PMID: 24202408 BACKGROUND

• Seon JK, Song EK, Yoon TR, Park SJ, Bae BH, Cho SG. Comparison of functional results with navigation-assisted minimally invasive and conventional techniques in bilateral total knee arthroplasty. Comput Aided Surg. 2007 May;12(3):189-93. doi: 10.3109/10929080701311861.

  PMID: 17538792 BACKGROUND

• Dutton AQ, Yeo SJ, Yang KY, Lo NN, Chia KU, Chong HC. Computer-assisted minimally invasive total knee arthroplasty compared with standard total knee arthroplasty. A prospective, randomized study. J Bone Joint Surg Am. 2008 Jan;90(1):2-9. doi: 10.2106/JBJS.F.01148.

  PMID: 18171951 BACKGROUND

• Luring C, Beckmann J, Haibock P, Perlick L, Grifka J, Tingart M. Minimal invasive and computer assisted total knee replacement compared with the conventional technique: a prospective, randomised trial. Knee Surg Sports Traumatol Arthrosc. 2008 Oct;16(10):928-34. doi: 10.1007/s00167-008-0582-2. Epub 2008 Jul 17.

  PMID: 18633597 BACKGROUND

• Hasegawa M, Yoshida K, Wakabayashi H, Sudo A. Minimally invasive total knee arthroplasty: comparison of jig-based technique versus computer navigation for clinical and alignment outcome. Knee Surg Sports Traumatol Arthrosc. 2011 Jun;19(6):904-10. doi: 10.1007/s00167-010-1253-7. Epub 2010 Sep 1.

  PMID: 20811732 BACKGROUND

• Beldame J, Boisrenoult P, Beaufils P. Pin track induced fractures around computer-assisted TKA. Orthop Traumatol Surg Res. 2010 May;96(3):249-55. doi: 10.1016/j.otsr.2009.12.005. Epub 2010 Apr 8.

  PMID: 20488143 BACKGROUND

• Hoke D, Jafari SM, Orozco F, Ong A. Tibial shaft stress fractures resulting from placement of navigation tracker pins. J Arthroplasty. 2011 Apr;26(3):504.e5-8. doi: 10.1016/j.arth.2010.05.009.

  PMID: 20663640 BACKGROUND

• Berning ET, Fowler RM. Thermal damage and tracker-pin track infection in computer-navigated total knee arthroplasty. J Arthroplasty. 2011 Sep;26(6):977.e21-4. doi: 10.1016/j.arth.2010.08.012. Epub 2010 Oct 14.

  PMID: 20950996 BACKGROUND

• Gulhane S, Holloway I, Bartlett M. A vascular complication in computer navigated total knee arthroplasty. Indian J Orthop. 2013 Jan;47(1):98-100. doi: 10.4103/0019-5413.106927.

  PMID: 23531499 BACKGROUND

• Keyes BJ, Markel DC, Meneghini RM. Evaluation of limb alignment, component positioning, and function in primary total knee arthroplasty using a pinless navigation technique compared with conventional methods. J Knee Surg. 2013 Apr;26(2):127-32. doi: 10.1055/s-0032-1319788. Epub 2012 Jul 13.

  PMID: 23288760 BACKGROUND

• Chen JY, Chin PL, Tay DK, Chia SL, Lo NN, Yeo SJ. Less outliers in pinless navigation compared with conventional surgery in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1827-32. doi: 10.1007/s00167-013-2456-5. Epub 2013 Mar 2.

  PMID: 23455388 BACKGROUND

• Chen JY, Chin PL, Li Z, Yew AK, Tay DK, Chia SL, Lo NN, Yeo SJ. Radiological outcomes of pinless navigation in total knee arthroplasty: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2015 Dec;23(12):3556-62. doi: 10.1007/s00167-014-3226-8. Epub 2014 Aug 14.

  PMID: 25119055 BACKGROUND

• Licini DJ, Meneghini RM. Modern abbreviated computer navigation of the femur reduces blood loss in total knee arthroplasty. J Arthroplasty. 2015 Oct;30(10):1729-32. doi: 10.1016/j.arth.2015.04.020. Epub 2015 Apr 23.

  PMID: 25971778 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jun-Wen Wang, MD

  Department of Orthopaedic Surgery, Kaohsiung Chang Gung Memorial Hospital

  STUDY DIRECTOR

Central Study Contacts

Shih-Hsiang Yen, MD

CONTACT

886-7-7317123; yswings@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study proposed 1:1 randomization into pinless navigation and conventional technique. Each patient who enrolled in this study will be given sequence study number, and the chief surgeon will draw lots to decide which group will be assigned in. The patient and the independent reviewer are kept blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enroll 100 patients who plan to undergo unilateral primary MIS-TKA and will be randomly assigned into two groups. The first group (50 patients) will be treated by pinless-navigation (Stryker, OrthoMap Express Knee Navigation) MIS-TKA, and the second group (50 patients) will undergo traditional MIS-TKA.

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 21, 2020
• Study Start: May 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)