All-Polyethylene Tibias in TKA: PS vs CS Implants

NCT03569670 | Withdrawn

• 1 other identifier: 110812
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized control trial where patients will be randomized to receive one of two types of total knee arthroplasty (TKA) all-polyethylene (AP) tibial components: cruciate retaining (CR) or posterior stabilized (PS). We will use radiostereometric analysis to assess the stability of the implants at 6 weeks, 3 months, 6 months, 1 year and 2 year post-operatively. The main objective of this project will be to determine which AP tibial component offers the greatest stability. Additionally, we will seek to determine whether patient BMI significantly impacts the stability of AP tibial components.

Conditions

Osteoarthritis, Knee

Keywords

cost; total knee replacement; arthroplasty; posterior stabilized; cruciate retaining; all-polyethylene

Outcome Measures

Primary Outcomes (1)

• Implant Migration

  Comparison of the two component types using radiostereometric analysis imaging.

  Change between baseline (taken at 2 weeks post-operatively) and 2 years

Secondary Outcomes (5)

• VR-12

  2 years

• Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)

  2 years

• Oxford Knee Score

  2 years

• EQ-5D

  2 years

• Cost

  Intraoperative

Study Arms (2)

Posterior Stabilized

EXPERIMENTAL

A posterior stabilized, all-polyethylene tibial component will be used during surgery.

Device: Posterior stabilized all-polyethylene tibial component

Cruciate Retaining

ACTIVE COMPARATOR

A cruciate retaining, all-polyethylene tibial component will be used during surgery.

Device: Cruciate retaining all-polyethylene tibial component

Interventions

Posterior stabilized all-polyethylene tibial component DEVICE

Patients randomized to this arm will have a Triathlon implant with a posterior stabilized, all-polyethylene tibial component used during surgery.

Posterior Stabilized

Cruciate retaining all-polyethylene tibial component DEVICE

Patients randomized to this arm will have a Triathlon implant with a cruciate retaining, all-polyethylene tibial component used during surgery.

Cruciate Retaining

Eligibility Criteria

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

You may qualify if:

• osteoarthritis
• primary total knee arthroplasty
• able to consent for themself

You may not qualify if:

• inflammatory arthropathy
• fibromyalgia
• chronic pain syndrome
• previous distal femur or proximal tibia open reduction internal fixation

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Western Ontario, Canada: collaborator

Study Sites (1)

London Health Sciences Centre - University Hospital

London, Ontario, N6A5A5, Canada

Location

Related Publications (7)

• Gioe TJ, Maheshwari AV. The all-polyethylene tibial component in primary total knee arthroplasty. J Bone Joint Surg Am. 2010 Feb;92(2):478-87. doi: 10.2106/JBJS.I.00842.

  PMID: 20124081 BACKGROUND

• Medel F, Kurtz SM, Klein G, Levine H, Sharkey P, Austin M, Kraay M, Rimnac CM. Clinical, surface damage and oxidative performance of poly II tibial inserts after long-term implantation. J Long Term Eff Med Implants. 2008;18(2):151-65. doi: 10.1615/jlongtermeffmedimplants.v18.i2.40.

  PMID: 19968624 BACKGROUND

• Adalberth G, Nilsson KG, Bystrom S, Kolstad K, Milbrink J. Low-conforming all-polyethylene tibial component not inferior to metal-backed component in cemented total knee arthroplasty: prospective, randomized radiostereometric analysis study of the AGC total knee prosthesis. J Arthroplasty. 2000 Sep;15(6):783-92. doi: 10.1054/arth.2000.8101.

  PMID: 11021456 BACKGROUND

• Yassin M, Garti A, Weissbrot M, Ashkenazi U, Khatib M, Robinson D. All-polyethylene tibial components are not inferior to metal-backed tibial components in long-term follow-up of knee arthroplasties. Eur J Orthop Surg Traumatol. 2015 Aug;25(6):1087-91. doi: 10.1007/s00590-015-1645-y. Epub 2015 May 26.

  PMID: 26006786 BACKGROUND

• Norgren B, Dalen T, Nilsson KG. All-poly tibial component better than metal-backed: a randomized RSA study. Knee. 2004 Jun;11(3):189-96. doi: 10.1016/S0968-0160(03)00071-1.

  PMID: 15194094 BACKGROUND

• Nouta KA, Verra WC, Pijls BG, Schoones JW, Nelissen RG. All-polyethylene tibial components are equal to metal-backed components: systematic review and meta-regression. Clin Orthop Relat Res. 2012 Dec;470(12):3549-59. doi: 10.1007/s11999-012-2582-2. Epub 2012 Sep 13.

  PMID: 22972656 BACKGROUND

• Valstar ER, Gill R, Ryd L, Flivik G, Borlin N, Karrholm J. Guidelines for standardization of radiostereometry (RSA) of implants. Acta Orthop. 2005 Aug;76(4):563-72. doi: 10.1080/17453670510041574.

  PMID: 16195075 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Edward Vasarhelyi, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: June 26, 2018
• Study Start: January 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: September 14, 2021

Record last verified: 2020-09

Locations

CA (1)