Comparison of CoCr Alloy and TiN Coating in TKA
Key facts
- Who runs it
- Medical University of Graz
- Where
- Austria1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- 10 Oct 2022
- Expected to end
- 1 Nov 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- TiN-alloy based total knee arthroplasty
- CoCr-coating based total knee arthroplasty
- Record updated
- 16 March 2023
- Why it stopped
- Implant to be analysed not used at study centre any more.
Who can take part
- Age
- 50 years to 90 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Knee osteoarthritis of index knee
- Varus angle < 15° of index knee
Who cannot take part
- Previous native knee infection of index knee
- Previous distal femoral fracture of index knee
- Previous proximal tibial fracture of index knee
- Known allergies against metals, drugs, organic substances
- Preceding osteotomy of index knee
- Unicondylar prosthetic replacement of index knee
- Knee osteoarthritis of both joints with planned simultaneous TKA
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Group A (TiN-coating)Treatment being tested
Patients with knee osteoarthritis receive total knee arthroplasty with Titanium-Nitride (TiN)-coated implant.
Treatment: TiN-alloy based total knee arthroplasty
- Group B (CoCr-alloy)Existing treatment, for comparison
Patients with knee osteoarthritis receive total knee arthroplasty with Cobalt-Chromium (CoCr)-alloy implant.
Treatment: CoCr-coating based total knee arthroplasty
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comparison of Cobalt-Chromium (CoCr) Alloy and Titanium-Nitride (TiN) Coating in Total Knee Arthroplasty: A Prospective, Randomised, Double-blinded Clinical Trial
- Record updated
- 16 March 2023