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

Valgus Malalignment of the Knee Clinical Trial

— Var_DFO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04382118
• Other study ID #: 2020-00108; ch20Muendermann3
• Status: Completed
• Start date: March 24, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: March 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Absence of informed consent

• Absence of X-Rays documenting the preoperative deformity or postoperative result

Related Conditions & MeSH terms

• Valgus Malalignment of the Knee

Intervention

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

Locations

Country	Name	City	State
Switzerland	Clinic for Orthopaedics and Traumatology, University Hospital basel	Basel	Basel Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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°)	at Baseline
Secondary	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	at Baseline
Secondary	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.	at Baseline
Secondary	pain medication intake preoperatively and at the final follow up	pain medication intake preoperatively and at the final follow up	at Baseline