Valgus Malalignment of the KneeVar_DFONCT04382118
Open Versus Closed Wedge Distal Femoral Varus Osteotomy for the Valgus Knee. Indications, Clinical and Radiological Outcome
An observational study of Valgus Malalignment of the Knee, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study is to analyze the indications of the two most popular techniques of distal femoral osteotomy (DFO) performed in patients with valgus malalignment and symptomatic degenerative changes in the lateral compartment of the knee and to evaluate the clinical and radiological outcome of a case series of patients who… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Valgus Malalignment of the Knee
- What is being tested?
- Data collection from routine medical records
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Mar 2020to 31 Oct 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who received a DFO for valgus knee arthritis at the Clinic of Orthopaedics and Traumatology at the University Hospital Basel between 1.1.2013 and 31.12.2017 will be included in this study.
Who may be able to join
- patients who received a distal femoral osteotomy (DFO) for valgus knee osteoarthritis between 1.1.2013 and 31.12.2017
Who cannot join
- Absence of informed consent
- Absence of X-Rays documenting the preoperative deformity or postoperative result
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic for Orthopaedics and Traumatology, University Hospital basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Var_DFO:Open Versus Closed Wedge Distal Femoral Varus Osteotomy for the Valgus Knee. Indications, Clinical and Radiological Outcome
This study is to analyze the indications of the two most popular techniques of distal femoral osteotomy (DFO) performed in patients with valgus malalignment and symptomatic degenerative changes in the lateral compartment of the knee and to evaluate the clinical and radiological outcome of a case series of patients who have received this operation at the Department of Orthopaedics and Traumatology and the Department of Surgery of the University Hospital Basel.
- Conditions
- Valgus Malalignment of the Knee
- Being tested
- Data collection from routine medical records
- Keywords
- Closed Wedge Distal Femoral Varus Osteotomy (CWDFO), Open Wedge Distal Femoral Varus Osteotomy (OWDFO)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection from routine medical recordsOther
Data collection from routine medical records (clinical and radiological data)
| Study group | Role | What they receive |
|---|---|---|
| OWDFO: Open Wedge Distal Femoral Varus osteotomy | Not described Receives: Other: Data collection from routine medical records | |
| CWDFO: Closed Wedge Distal Femoral Varus osteotomy | Not described Receives: Other: Data collection from routine medical records |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the correction of the deformity
The mechanical axis of the femur and the tibia and hence the mechanical tibiofemoral angle (MFTA) will be measured pre- and postoperatively. (the goal of the operation is a neutral alignment, MFTA angle of 0°)
Measured: at Baseline
Secondary outcomes (3)
incidence of disruptive hardware
Information regarding the incidence of disruptive hardware and of hardware removal operations because of this, time needed until bony union is achieved, complications, delayed and non-union rates and need of conversion to arthroplasty
Measured: at Baseline
pain level
Information regarding pain levels measured with visual analog scale score (VAS). The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. It consists of a line, approximately 10-15 cm in length, with the left side signifying no pain with a smiling face image and the right side signifying the worst pain.
Measured: at Baseline
pain medication intake preoperatively and at the final follow up
pain medication intake preoperatively and at the final follow up
Measured: at Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start24 Mar 2020
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Valgus Malalignment of the KneeStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annegret Muendermann, Prof. Dr. med., Principal investigator, Department of Orthopaedics and Traumatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382118
- Sponsor's protocol ID
- 2020-00108; ch20Muendermann3
- Acronym
- Var_DFO
- Status last verified
- Mar 2022
- First submitted
- 6 May 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ismailidis P, Schmid C, Werner J, Nuesch C, Mundermann A, Pagenstert G, Egloff C. Distal femoral osteotomy for the valgus knee: indications, complications, clinical and radiological outcome. Arch Orthop Trauma Surg. 2023 Oct;143(10):6147-6157. doi: 10.1007/s00402-023-04923-w. Epub 2023 Jun 6.
PubMed 37278744
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Var_DFO:Open Versus Closed Wedge Distal Femoral Varus Osteotomy for the Valgus Knee. Indications, Clinical and Radiological Outcome
- ClinicalTrials.gov ID
- NCT04382118
- Acronym / sponsor ID
- Var_DFO / 2020-00108; ch20Muendermann3
- Conditions
- Valgus Malalignment of the Knee
- Keywords
- Closed Wedge Distal Femoral Varus Osteotomy (CWDFO), Open Wedge Distal Femoral Varus Osteotomy (OWDFO)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 11 May 2020 (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.
This study is to analyze the indications of the two most popular techniques of distal femoral osteotomy (DFO) performed in patients with valgus malalignment and symptomatic degenerative changes in the lateral compartment of the knee and to evaluate the clinical and radiological outcome of a case series of patients who have received this operation at the Department of Orthopaedics and Traumatology and the Department of Surgery of the University Hospital Basel.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OWDFO: Open Wedge Distal Femoral Varus osteotomy | – | Other: Data collection from routine medical records |
| CWDFO: Closed Wedge Distal Femoral Varus osteotomy | – | Other: Data collection from routine medical records |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who received a DFO for valgus knee arthritis at the Clinic of Orthopaedics and Traumatology at the University Hospital Basel between 1.1.2013 and 31.12.2017 will be included in this study.
Key inclusion criteria (1 listed)
- patients who received a distal femoral osteotomy (DFO) for valgus knee osteoarthritis between 1.1.2013 and 31.12.2017
Key exclusion criteria (2 listed)
- Absence of informed consent
- Absence of X-Rays documenting the preoperative deformity or postoperative result
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 |
|---|---|---|
| Data collection from routine medical recordsData collection from routine medical records (clinical and radiological data) | Other | CWDFO: Closed Wedge Distal Femoral Varus osteotomy, OWDFO: Open Wedge Distal Femoral Varus osteotomy |
Primary outcome
Accuracy of the correction of the deformity
Time frame: at Baseline
The mechanical axis of the femur and the tibia and hence the mechanical tibiofemoral angle (MFTA) will be measured pre- and postoperatively. (the goal of the operation is a neutral alignment, MFTA angle of 0°)
3 secondary outcomes
incidence of disruptive hardware
Time frame: at Baseline
pain level
Time frame: at Baseline
pain medication intake preoperatively and at the final follow up
Time frame: at Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Derived from this study: PubMed 37278744Ismailidis P, Schmid C, Werner J, Nuesch C, Mundermann A, Pagenstert G, Egloff C. Distal femoral osteotomy for the valgus knee: indications, complications, clinical and radiological outcome. Arch Orthop Trauma Surg. 2023 Oct;143(10):6147-6157. doi: 10.1007/s00402-023-04923-w. Epub 2023 Jun 6.
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.
Annegret Muendermann, Prof. Dr. med. principal investigator
Department of Orthopaedics and Traumatology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valgus Malalignment of the Knee, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 15 Mar 2022. 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 Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accuracy of the correction of the deformity (time frame: at Baseline). 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 NCT04382118, which also lists 1 linked publication.
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 15 Mar 2022.