The effect of total knee arthroplasty (replacement) with the flexion first balancer or measured resection technique
| ISRCTN | ISRCTN85351296 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85351296 |
| Secondary identifying numbers | W18.007 |
- Submission date
- 07/04/2021
- Registration date
- 23/04/2021
- Last edited
- 13/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
Knee replacement surgery (arthroplasty) is a common operation that involves replacing a damaged, worn or diseased knee with an artificial joint. Adults of any age can be considered for a knee replacement, although most are carried out on people between the ages of 60 and 80.
With the use of a new technique, Flexion First Balancer (FFB), we are able to restore the joint line to its predisease level. We expect better functional outcome for these patients when we compare them to a matched patient group who were operated using the conventional technique, i.e. Measured resection (MR).
The difference between the two techniques is that in MR technique, a standardized amount of bone is resected to accommodate the knee prosthesis. First in extension these bone cuts are made and then in flexion. Resulting in an equal flexion and extension gap and therefore creating a stable knee prosthesis. Since the native medial and lateral side of the knee are not the same this might result in standard error with slight elevation of the joint line as a consequence.
In the Flexion First Balancer technique the bone cuts are first made in flexion and are dictated by the medial collateral ligament tension and therefore restores the medial knee anatomy. Later this flexion gap is copied to the extension gap and these extension cuts are dictated by the natural ligament tension of the knee. Therefore a more natural placement of the knee is possible which might benefit the patient.
Who can participate?
Patients who underwent TKA surgery via the FFB technique for Kellgren-Lawrence grade 3-4 osteoarthritis between September 2015 and November 2016, and patients who were operated on using the standard MR technique between September 2014 and July 2015
What does the study involve?
Two additional X-rays will be made to assess midflexion instability. Furthermore, three functional tests (6 minute walk test, stair climb test, static Quadriceps power test) will be conducted to examine functional outcome.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Amphia Hospital in Breda (the Netherlands)
When is the study starting and how long is it expected to run for?
August 2018 to June 2019
Who is funding the study?
Amphia Hospital Wetenschapsfonds (Science-funding) (the Netherlands)
Who is the main contact?
W. van Lieshout, wvanlieshout@gmail.com
Contact information
Public
Michiel van Miereveldlaan 6
Amstelveen
1181TM
Netherlands
 ORCID ID |
0000-0002-2220-6179 |
|---|---|
| Phone | +31(0)638304878 |
| wvanlieshout@gmail.com |
Study information
| Study design | Cross-sectional cohort study single centre |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN85351296_PIS_v3_09Aug2018_in_Dutch.pdf |
| Scientific title | Midflexion Instability and Functional Outcome after total knee arthroplasty: flexion first balancer versus measured resection technique. The MIFO study |
| Study acronym | MIFO |
| Study hypothesis | Since the FFB technique restores the joint line to its pre-disease height this would result in less coronal mid-flexion laxity. Which, in turn could result in better functional outcome compared to the standard MR technique due to increased stability in the knee. |
| Ethics approval(s) | Approved 05/09/2018, MEC-U (Koekoekslaan 1, Nieuwegein, 3430 EM, Netherlands; +31(0)306093580; info@mec-u.nl), ref: NL65535.100.18 |
| Condition | Total knee replacement for osteoarthritis |
| Intervention | This cross-sectional study has compared a group of patients operated with the Flexion First Balancer technique to a matched group who were operated using the conventional technique (Measured Resection). Two additional X-rays were made with either varus or valgus stress in 30 degrees of flexion to assess midflexion instability. Futhermore, three functional tests (6 minute walk test, stair climb test, static Quadriceps power test) were conducted to examine the functional outcome. The mean time from TKA was: Follow up, mean (sd) 3.9 yrs (0.2) 2.6 yrs (0.4) The investigation duration was 1 hour per person. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Mid flexion laxity measured in millimetres on the medial or lateral side with either valgus or varus stress in 30 degrees of knee flexion measured at mean 3.9 years for the Measured resection group and a mean 2.6 years for the Flexion First Balancer group |
| Secondary outcome measures | Functional outcomes measured at mean 3.9 years for the Measured resection group and a mean 2.6 years for the Flexion First Balancer group: 1. 6 minute walk test 2. Stair climb test 3. Static Quadriceps power test |
| Overall study start date | 01/08/2018 |
| Overall study end date | 01/06/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 55 |
| Participant inclusion criteria | 1. Patients who underwent TKA surgery via the FFB technique for Kellgren-Lawrence grade 3-4 osteoarthritis between September 2015 and November 2016 2. A historical matched cohort of patients who were operated on using the standard MR technique between September 2014 and July 2015 was used |
| Participant exclusion criteria | 1. Ill health 2. Degenerative diseases (e.g. rheumatoid arthritis) or development of severe osteoarthritis influencing functional test outcomes 3. Complications requiring consecutive surgery 4. Hip replacement or contralateral TKA within the past year. |
| Recruitment start date | 01/09/2018 |
| Recruitment end date | 01/04/2019 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Breda
4818 CK
Netherlands
Sponsor information
Research council
Amphia Wetenschapscommisie
Molengracht 21
Breda
4818 CK
Netherlands
| Phone | +31 (0)765954251 |
|---|---|
| wetenschap@amphia.nl | |
| Website | https://www.amphia.nl/opleiding-en-wetenschap/wetenschap/indieningsproces-wetenschappelijk-onderzoek |
"ROR" |
https://ror.org/01g21pa45 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/05/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in high -impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v3 | 09/08/2018 | 04/05/2021 | No | Yes |
| Results article | 09/12/2021 | 13/01/2022 | Yes | No |
Additional files
- ISRCTN85351296_PIS_v3_09Aug2018_in_Dutch.pdf
- uploaded 04/05/2021
Editorial Notes
13/01/2022: Publication reference added.
04/05/2021: The participant information sheet was uploaded as an additional file.
22/04/2021: Trial's existence confirmed by MEC-U.
