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CompletedNCT04382118Var_DFOUpdated Mar 15, 2022

Open Versus Closed Wedge Distal Femoral Varus Osteotomy for the Valgus Knee. Indications, Clinical and Radiological Outcome

An observational study in Valgus Malalignment of the Knee, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2022-03-15.

Sponsored by University Hospital, Basel, Switzerland · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
22
Sex
All
01

Study 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 have received this operation at the Department of Orthopaedics and Traumatology and the Department of Surgery of the University Hospital Basel.

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Conditions studied

  • Valgus Malalignment of the Knee

Keywords

  • Closed Wedge Distal Femoral Varus Osteotomy (CWDFO)
  • Open Wedge Distal Femoral Varus Osteotomy (OWDFO)
03

In context

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  • patients who received a distal femoral osteotomy (DFO) for valgus knee osteoarthritis between 1.1.2013 and 31.12.2017

Exclusion criteria

Exclusion Criteria:

  • Absence of informed consent
  • Absence of X-Rays documenting the preoperative deformity or postoperative result
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
22 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherData collection from routine medical records

    Data collection from routine medical records (clinical and radiological data)

06

What researchers measure

Primary outcomes

  1. 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°)

    Time frame: at Baseline

Secondary outcomes

  1. 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

    Time frame: at Baseline

  2. 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.

    Time frame: at Baseline

  3. pain medication intake preoperatively and at the final follow up

    pain medication intake preoperatively and at the final follow up

    Time frame: at Baseline

07

Study locations

1 site
  • Clinic for Orthopaedics and Traumatology, University Hospital basel
    Basel, Basel Stadt 4031, Switzerland
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04382118
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
May 11, 2020
Start date
Mar 24, 2020
Primary completion
Oct 31, 2021
Completion
Oct 31, 2021
Last update
Mar 15, 2022

Study contacts

Annegret Muendermann, Prof. Dr. med.
principal investigator · Department of Orthopaedics and Traumatology, University Hospital Basel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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