Comparison of CoCr Alloy and TiN Coating in TKA

March 14, 2023 updated by: Medical University of Graz

Comparison of Cobalt-Chromium (CoCr) Alloy and Titanium-Nitride (TiN) Coating in Total Knee Arthroplasty: A Prospective, Randomised, Double-blinded Clinical Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Rationale

The present double-blinded study was planned in order to assess whether differences in materials - using one otherwise similar TKA system - would have an effect on postoperative patient outcome. Moreover, metal ion levels will be measured in the blood stream preoperatively (as reference) and upon follow-up, based on previous observations that metal ion levels are increased in serum following TKA, without any relevant influence on outcome.

Aims

The aim of the present prospective study is to assess whether differences in tribological pairings - i.e. TiN-coating in comparison to CoCr-alloy using a frequently implanted total knee endoprosthesis (ACS® System, Implantcast GmbH, Buxtehude, Germany) - have an effect on postoperative range of motion (ROM) and patient satisfaction, reflected by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Forgotten Joint Score (FJS), Knee Society Score (KSS), Visual Analogue Scale (VAS). Moreover, metal ion levels will be tested in both groups to monitor their concentration in the blood stream, usually reflecting physiological abrasion.

Endpoints

The primary endpoint of the current study is the functional outcome of patients with TKA on a CoCrMo- basis in comparison to a TiN-coated implant. The secondary endpoint is the measurement of metal ion levels in the blood stream and their potential dynamics over time.

Methods

Two-hundred patients will be prospectively included in the study over a 4-year period, with 100 being randomly assigned to group A (TiN-coating) and 100 to group B (CoCr-alloy).

Random assignment will be carried out via an automatic randomisation system run by a local study nurse. Pre- and postoperatively, range of motion (ROM), visual analogue scale (VAS) score and specific questionnaires - i.e. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Forgotten Joint Score (FJS), Knee Society Score (KSS) - will be ascertained (Table 1) in order to allow comparison of potential differences between group A and B during follow-up. Furthermore, preoperatively, at 6 months, 12 months, 24 months and 60 months, metal ion levels (cobalt, chromium, molybdenum, titanium) in the blood stream will be measured in each patient (6ml tubes). Measurements of metal ion levels will be performed at an external institution.

The phase of active recruiting is planned for 4 years, with 50 patients being included per year on average. With the last patients anticipated to being included at the end of the 4th year, their follow-up will be finished 9 years after study initiation.

Randomisation and Blinding

All patients will be informed prior to potential study participation whether or not to they would like to participate, clarifying that refusal will not have any negative impact on further treatment. In case patients agree to participate, they will be randomly assigned to either group A or B.

Double-blinding will be made possible by not informing patients whether they had been allocated to group A or B and by not directly revealing information about the implant type used on medical records that will later be accessible to the study nurse and/or physicians during clinical examinations at follow- up. Therefore, it will be necessary to exclude those surgeons participating in the surgeries of the respective patients from examining them during follow-up, in order to maintain blinding. Prior to follow-up appointments, surgeons who had not participated in surgeries of the respective patients will thus be informed by the study nurse in order to perform clinical examination, radiological follow-up and questionnaires.

Expected Results

As patients receive the identical orthopaedic implant during an identical surgical procedure for comparable indications, it is expected that the differences in alloy (i.e. TiN vs. CoCr) will not have a measurable effect on postoperative patient outcome. Neither there is expected to be a difference in metal ion levels in the blood stream over time between groups.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Department of Orthopaedics and Trauma, Medical University of Graz, Austria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (TiN-coating)
Patients with knee osteoarthritis receive total knee arthroplasty with Titanium-Nitride (TiN)-coated implant.
Device: TiN-alloy based total knee arthroplasty
TiN-alloy based TKA implanted for knee osteoarthritis.
Other Names:
  • ACS System, Implantcast GmbH, Buxtehude, Germany
Active Comparator: Group B (CoCr-alloy)
Patients with knee osteoarthritis receive total knee arthroplasty with Cobalt-Chromium (CoCr)-alloy implant.
Device: CoCr-coating based total knee arthroplasty
CoCr-coating based TKA implanted for knee osteoarthritis.
Other Names:
  • ACS System, Implantcast GmbH, Buxtehude, Germany

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Postoperative functional outcome - ROM with goniometer
Time Frame: Preoperatively, postoperative week 6, month 12, month 24, month 60.
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
Time Frame: Preoperatively, postoperative week 6, month 12, month 24, month 60.
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)
Time Frame: Preoperatively, postoperative week 6, month 12, month 24, month 60.

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
Time Frame: Preoperatively, postoperative week 6, month 12, month 24, month 60.
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)
Time Frame: Preoperatively, postoperative week 6, month 12, month 24, month 60.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Metal ion levels in blood stream
Time Frame: Preoperatively, month 6, month 12, month 24, month 60.
Measurement of titanium, cobalt, chromium, molybdenum in blood stream at specific time-points.
Preoperatively, month 6, month 12, month 24, month 60.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

Alphamed Medizintechnik Fischer GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 10, 2022

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2029

Study Registration Dates

First Submitted

October 30, 2020

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1533/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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