Osteoarthritis, KneeNCT04701359
Comparison of CoCr Alloy and TiN Coating in TKA
A study testing TiN-alloy based total knee arthroplasty and CoCr-coating based total knee arthroplasty in people with Osteoarthritis, Knee and Arthroplasty, Replacement, Knee, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee, Arthroplasty, Replacement, Knee
- What is being tested?
- TiN-alloy based total knee arthroplasty and CoCr-coating based total knee arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- 10 Oct 2022to 1 Nov 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee osteoarthritis of index knee
- Varus angle < 15° of index knee
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Orthopaedics and Trauma, Medical University of Graz, Austria
Graz, 8036
About this study
Official title: 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.
Read the 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.
- Being tested
- TiN-alloy based total knee arthroplasty, CoCr-coating based total knee arthroplasty
- Keywords
- Implant coating/alloy, Titanium-Nitride (TiN) coating, Cobalt-Chromium (CoCr) alloy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiN-alloy based total knee arthroplastyDevice
Also called ACS System, Implantcast GmbH, Buxtehude, Germany
TiN-alloy based TKA implanted for knee osteoarthritis.
CoCr-coating based total knee arthroplastyDevice
Also called ACS System, Implantcast GmbH, Buxtehude, Germany
CoCr-coating based TKA implanted for knee osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| Group A (TiN-coating) | Experimental | Patients with knee osteoarthritis receive total knee arthroplasty with Titanium-Nitride (TiN)-coated implant. Receives: 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. Receives: Device: CoCr-coating based total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Postoperative functional outcome - ROM with goniometer
Range of motion (ROM), assessed with goniometer approved for medical issues
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: Preoperatively, postoperative week 6, month 12, month 24, month 60.
Secondary outcomes (1)
Change of Metal ion levels in blood stream
Measurement of titanium, cobalt, chromium, molybdenum in blood stream at specific time-points.
Measured: Preoperatively, month 6, month 12, month 24, month 60.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start10 Oct 2022 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2029 (estimated)
Why it stopped: Implant to be analysed not used at study centre any more.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Alphamed Medizintechnik Fischer GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701359
- Sponsor's protocol ID
- 1533/2020
- Status last verified
- Mar 2023
- First submitted
- 30 Oct 2020
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 28528349Fennema 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.
PubMed 24774225Gudnason 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.
PubMed 24951734Lapaj 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.
PubMed 26584076Longo 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.
PubMed 27209191Paxton 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.
PubMed 25567357Postler 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.
PubMed 29616285
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cobalt-Chromium (CoCr) Alloy and Titanium-Nitride (TiN) Coating in Total Knee Arthroplasty: A Prospective, Randomised, Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT04701359
- Acronym / sponsor ID
- 1533/2020
- Keywords
- Implant coating/alloy, Titanium-Nitride (TiN) coating, Cobalt-Chromium (CoCr) alloy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Implant to be analysed not used at study centre any more.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Alphamed Medizintechnik Fischer GmbH
- Study start
- 10 Oct 2022 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group A (TiN-coating) | Experimental | Device: TiN-alloy based total knee arthroplastyPatients with knee osteoarthritis receive total knee arthroplasty with Titanium-Nitride (TiN)-coated implant. |
| Group B (CoCr-alloy) | Active comparator | Device: CoCr-coating based total knee arthroplastyPatients with knee osteoarthritis receive total knee arthroplasty with Cobalt-Chromium (CoCr)-alloy implant. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Knee osteoarthritis of index knee
- Varus angle < 15° of index knee
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TiN-alloy based total knee arthroplastyAlso: ACS System, Implantcast GmbH, Buxtehude, GermanyTiN-alloy based TKA implanted for knee osteoarthritis. | Device | Group A (TiN-coating) |
| CoCr-coating based total knee arthroplastyAlso: ACS System, Implantcast GmbH, Buxtehude, GermanyCoCr-coating based TKA implanted for knee osteoarthritis. | Device | Group B (CoCr-alloy) |
Primary outcome
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
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)
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
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
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.
1 secondary outcome
Change of Metal ion levels in blood stream
Time frame: Preoperatively, month 6, month 12, month 24, month 60.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Background: PubMed 28528349Fabry 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.
- Background: PubMed 24774225Fennema 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.
- Background: PubMed 24951734Gudnason 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.
- Background: PubMed 26584076Lapaj 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.
- Background: PubMed 27209191Longo 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.
- Background: PubMed 25567357Paxton 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.
- Background: PubMed 29616285Postler 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TiN-alloy based total knee arthroplasty and CoCr-coating based total knee arthroplasty in people with Osteoarthritis, Knee and Arthroplasty, Replacement, Knee, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Postoperative functional outcome - ROM with goniometer (time frame: Preoperatively, postoperative week 6, month 12, month 24, month 60.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04701359, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.