Is there a difference in clinical outcome, pain, and range of motion between fixed and mobile bearing Attune total knee replacement?
| ISRCTN | ISRCTN15117998 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15117998 |
| Secondary identifying numbers | 30-352 ex 17/18 |
- Submission date
- 25/03/2022
- Registration date
- 04/04/2022
- Last edited
- 01/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Despite numerous scientific investigations, the tribological advantages of mobile bearing inserts have not been sustainably confirmed or refuted for modern knee prostheses in clinical studies. Simultaneously, total knee prostheses have substantially improved, especially in terms of the quality of polyethylene and fixation methods. Recent long term randomized controlled trials with large cohorts and literature reviews reported of no differences in durability, function, range of movement and migration. Modern total knee prostheses, such as the presented implant type (Attune®) provide a transition from stability and rotational freedom. This is the first study to analyze subjective and objective measurements between FB and MB inserts of this well-established TKA system.
Who can participate?
Every patient with end stage osteoarthritis that visited the outpatient department for Knee surgery at the Medical University of Graz between December 2015 and December 2016 was able to participate in this present study.
What does the study involve?
The study involves a surgical treatment (Total Knee Arthroplasty) and follow-up examinations over a 2-year follow-up period.
What are the possible benefits and risks of participating?
There were no specific or clinically relevant risks of participating as only as two well established Total Knee Arthroplasty systems were used in this present study.
Where is the study run from?
Medical University of Graz (Austria)
When is the study starting and how long is it expected to run for?
March 2018 to February 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Dr. med. Patrick Sadoghi, patrick.sadoghi@medunigraz.at
Contact information
Public
Auenbruggerplatz 5
Graz
8036
Austria
| Phone | +43 31638513358 |
|---|---|
| paul.ruckenstuhl@medunigraz.at |
Scientific
Department of Orthopaedics and Trauma
Medical University of Graz
Auenbruggerplatz 5
Graz
A-8036
Austria
 ORCID ID |
0000-0003-1767-555X |
|---|---|
| Phone | +43 316 385 81580 |
| patrick.sadoghi@medunigraz.at |
Study information
| Study design | Prospective single center cohort study of 2 non-randomized stratified groups |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | No difference in clinical outcome, pain, and range of motion between fixed and mobile bearing Attune total knee arthroplasty. A prospective single-center trial. |
| Study objectives | The purpose of this study was to compare fixed and mobile bearing inserts in order to draw conclusions regarding clinical benefits. |
| Ethics approval(s) | Approved 22/03/2018, Ethics committee of the Medical University of Graz (Auenbruggerplatz 2, 8036 Graz, Austria; +43 316 385 13928; ethikkommission@medunigraz.at), ref: 30-352 ex 17/18 |
| Health condition(s) or problem(s) studied | Comparison between fixed and mobile bearing inserts for Total Knee Arthroplasty in order to draw conclusions regarding clinical benefits |
| Intervention | All patients either received a fixed or mobile bearing insert during Total Knee Arthroplasty. The decision whether a patient received a mobile or fixed insert was made prior to the surgery based in a non-randomized setting. During the operation, the selection of insert type was not changed in any case. Participants were followed up for a minimum of 2 years. Between January 2015 and December 2016, a total of 544 primary total knee arthroplasties were implanted at one single orthopedic center. During this period another prospective level II study was conducted selecting patients of this time interval (n=200). The remaining 344 patients were eligible for the presented study. All patients either received a fixed or mobile bearing insert. The decision whether a patient received a MB of FB insert was made prior to the surgery based in a non-randomized setting. During the operation the selection of insert type was not changed in any case. Patients with a secondary arthritis, previous knee surgeries except arthroscopies, and varus/valgus-deformities of more than 20° were excluded. Moreover, we only included patients treated with one well-proved and worldwide used type of implant (Attune®, DePuy-Synthes, Warsaw, Indiana). All implants were tibial and femoral fixed with cement. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cemented total knee arthroplasty (Attune®) treated with a mobile or a fixed insert. |
| Primary outcome measure | Measured at for a minimum of 2 years follow-up. 1. Subjective assessment of success using the WOMAC score 2. Subjective assessment of success using Visual Analogue Scale 3. Range of Motion using the Knee-Society-Score |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 22/03/2018 |
| Completion date | 04/02/2020 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 85 |
| Key inclusion criteria | 1. End staged-osteoarthritis of the Knee Joint 2. Patients between 50-80 years of age 3. Signed consent to participate in the present study |
| Key exclusion criteria | 1. Secondary Arthritis 2. Varus/Valgus deformities of more than 20° 3. Previous knee surgery except arthroscopy |
| Date of first enrolment | 01/01/2015 |
| Date of final enrolment | 31/12/2016 |
Locations
Countries of recruitment
- Austria
Study participating centre
Graz
8036
Austria
Sponsor information
University/education
Auenbruggerpl. 5
Graz
8036
Austria
| Phone | +43 316 38513358 |
|---|---|
| ortho.trauma@uniklinikum.kages.at | |
| Website | http://www.medunigraz.at/en/ |
"ROR" |
https://ror.org/02n0bts35 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | Available on request patrick.sadoghi@medunigraz.at |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 04/04/2022 | No | No | ||
| Results article | 02/05/2022 | 22/09/2022 | Yes | No |
Additional files
Editorial Notes
22/09/2022: Publication reference added.
04/04/2022: Trial's existence confirmed by Medical University of Graz.
