NCT04701359

Brief Summary

In the current prospective, randomized study, two different materials of the same total knee arthroplasty (TKA) system - cobalt-chromium (CoCr) and titanium-nitride (TiN) - are going to be compared with regards to postoperative outcome. Two-hundred patients are planned to be included in the study over a 4-year period, randomly assigned to either the CoCr- or TiN-implant-group. In order to ensure double-blinding, patients will not be informed about the group they had been assigned to. Moreover, no identifying information of the implant used will be written on documents later accessible to nurses and/or physicians at follow-up appointments. Consequently, surgeons of the respective patients will be excluded from study-specific examination of patients. Despite range of motion (ROM), questionnaires (visual analogue scale - VAS; Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC, Forgotten Joint Score - FJS; Knee Society Scoe - KSS) will be used to assess the postoperative outcome. Furthermore, metal ion levels (cobalt, chrom, molybdenum, titanium) in the blood stream of patients will be measured at scheduled follow-up appointments. It is expected that there will not be a measureable difference between the two coating-groups with regards to ROM, functionality, and metal-ion levels over time.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
41mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Oct 2022Nov 2029

First Submitted

Initial submission to the registry

October 30, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
1.8 years until next milestone

Study Start

First participant enrolled

October 10, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2029

Expected
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

2.1 years

First QC Date

October 30, 2020

Last Update Submit

March 14, 2023

Conditions

Osteoarthritis, KneeArthroplasty, Replacement, Knee

Keywords

Implant coating/alloyTitanium-Nitride (TiN) coatingCobalt-Chromium (CoCr) alloy

Outcome Measures

Primary Outcomes (5)

  • Change of Postoperative functional outcome - ROM with goniometer

    Range of motion (ROM), assessed with goniometer approved for medical issues

    Preoperatively, postoperative week 6, month 12, month 24, month 60.

  • Change of Postoperative functional outcome - pain

    VAS score (Visual Analogue Scale; 0 = no pain, 10 = severe pain)

    Preoperatively, postoperative week 6, month 12, month 24, month 60.

  • Change of Postoperative functional outcome - Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Assessed by Western Ontario and McMaster Universities Arthritis Index (WOMAC). This index ranges from 0 to 100 points and is based on items pain, physical function and joint stiffness. Lower values indicating better outcomes, whilst higher values point towards worse outcome. Higher scores on the WOMAC indicate a worse outcome

    Preoperatively, postoperative week 6, month 12, month 24, month 60.

  • Change of Postoperative functional outcome - FJS

    Forgotten Joint Score (FJS) with a scale ranging from 0 to 100, where a high value indicates a better outcome

    Preoperatively, postoperative week 6, month 12, month 24, month 60.

  • Change of Postoperative functional outcome - Knee Society Score (KSS)

    Knee society score (KSS) is built up by two scores, i.e. "Functional Score" (3 items) and "Knee Score" (7 items), both ranging from 0 to 100 points. The lower the values, the worse the outcome.

    Preoperatively, postoperative week 6, month 12, month 24, month 60.

Secondary Outcomes (1)

  • Change of Metal ion levels in blood stream

    Preoperatively, month 6, month 12, month 24, month 60.

Study Arms (2)

Group A (TiN-coating)

EXPERIMENTAL

Patients with knee osteoarthritis receive total knee arthroplasty with Titanium-Nitride (TiN)-coated implant.

Device: TiN-alloy based total knee arthroplasty

Group B (CoCr-alloy)

ACTIVE COMPARATOR

Patients with knee osteoarthritis receive total knee arthroplasty with Cobalt-Chromium (CoCr)-alloy implant.

Device: CoCr-coating based total knee arthroplasty

Interventions

TiN-alloy based total knee arthroplastyDEVICE

TiN-alloy based TKA implanted for knee osteoarthritis.

Also known as: ACS System, Implantcast GmbH, Buxtehude, Germany
Group A (TiN-coating)
CoCr-coating based total knee arthroplastyDEVICE

CoCr-coating based TKA implanted for knee osteoarthritis.

Also known as: ACS System, Implantcast GmbH, Buxtehude, Germany
Group B (CoCr-alloy)

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Knee osteoarthritis of index knee
  • Varus angle \< 15° of index knee

You may not qualify if:

  • Previous native knee infection of index knee
  • Previous distal femoral fracture of index knee
  • Previous proximal tibial fracture of index knee
  • Preceding osteotomy of index knee
  • Known allergies against metals, drugs, organic substances
  • Unicondylar prosthetic replacement of index knee
  • Knee osteoarthritis of both joints with planned simultaneous TKA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics and Trauma, Medical University of Graz, Austria

Graz, 8036, Austria

Location

Related Publications (7)

  • Fabry C, Zietz C, Baumann A, Ehall R, Bader R. High wear resistance of femoral components coated with titanium nitride: a retrieval analysis. Knee Surg Sports Traumatol Arthrosc. 2018 Sep;26(9):2630-2639. doi: 10.1007/s00167-017-4578-7. Epub 2017 May 20.

    PMID: 28528349BACKGROUND

  • Fennema P, Heyse TJ, Uyl-de Groot CA. Cost-effectiveness and clinical implications of advanced bearings in total knee arthroplasty: a long-term modeling analysis. Int J Technol Assess Health Care. 2014 Apr;30(2):218-25. doi: 10.1017/S0266462314000129. Epub 2014 Apr 28.

    PMID: 24774225BACKGROUND

  • Gudnason A, Hailer NP, W-Dahl A, Sundberg M, Robertsson O. All-Polyethylene Versus Metal-Backed Tibial Components-An Analysis of 27,733 Cruciate-Retaining Total Knee Replacements from the Swedish Knee Arthroplasty Register. J Bone Joint Surg Am. 2014 Jun 18;96(12):994-999. doi: 10.2106/JBJS.M.00373.

    PMID: 24951734BACKGROUND

  • Lapaj L, Wendland J, Markuszewski J, Mroz A, Wisniewski T. Retrieval analysis of titanium nitride (TiN) coated prosthetic femoral heads articulating with polyethylene. J Mech Behav Biomed Mater. 2015 Mar;55:127-139. doi: 10.1016/j.jmbbm.2015.10.012. Epub 2015 Oct 30.

    PMID: 26584076BACKGROUND

  • Longo UG, Ciuffreda M, D'Andrea V, Mannering N, Locher J, Denaro V. All-polyethylene versus metal-backed tibial component in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Nov;25(11):3620-3636. doi: 10.1007/s00167-016-4168-0. Epub 2016 May 21.

    PMID: 27209191BACKGROUND

  • Paxton EW, Inacio MC, Kurtz S, Love R, Cafri G, Namba RS. Is there a difference in total knee arthroplasty risk of revision in highly crosslinked versus conventional polyethylene? Clin Orthop Relat Res. 2015 Mar;473(3):999-1008. doi: 10.1007/s11999-014-4046-3.

    PMID: 25567357BACKGROUND

  • Postler A, Beyer F, Lutzner C, Tille E, Lutzner J. Similar outcome during short-term follow-up after coated and uncoated total knee arthroplasty: a randomized controlled study. Knee Surg Sports Traumatol Arthrosc. 2018 Nov;26(11):3459-3467. doi: 10.1007/s00167-018-4928-0. Epub 2018 Apr 3.

    PMID: 29616285BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Masking of both patients and outcome assessors. Only care provider (i.e. surgeon) and investigator aware of implant-type used. During follow-up, neither care provider nor investigator allowed to assess patients' study-specific outcome. As implants look identical on X-rays, allocation to one or another group cannot be verified by independent outcome assessors.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-hundred patients with knee osteoarthritis included altogether. Patients randomly assigned to group A (receiving total knee arthroplasty \[TKA\] with TiN-coating) or group B (receiving TKA with CoCr-alloy).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2020

First Posted

January 8, 2021

Study Start

October 10, 2022

Primary Completion

November 1, 2024

Study Completion (Estimated)

November 1, 2029

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

It is not planned to share the IPD in full. However, results of the study are planned to be made public within a scientific work.

Locations

AU(1)