NCT04382118

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

May 6, 2020

Last Update Submit

March 14, 2022

Conditions

Keywords

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

Outcome Measures

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°)

    at Baseline

Secondary Outcomes (3)

  • incidence of disruptive hardware

    at Baseline

  • pain level

    at Baseline

  • pain medication intake preoperatively and at the final follow up

    at Baseline

Study Arms (2)

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

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

CWDFO: Closed Wedge Distal Femoral Varus osteotomyOWDFO: Open Wedge Distal Femoral Varus osteotomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Orthopaedics and Traumatology, University Hospital basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (1)

  • 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.

Study Officials

  • Annegret Muendermann, Prof. Dr. med.

    Department of Orthopaedics and Traumatology, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 11, 2020

Study Start

March 24, 2020

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

March 15, 2022

Record last verified: 2022-03

Locations