Medial Augmentation Plating of Aseptic Distal Femoral Nonunions.
- Conditions
- M84.1Nonunion of fracture [pseudarthrosis]
- Registration Number
- DRKS00031961
- Lead Sponsor
- Berufsgenosschaftliches Universitätsklinkum Bergmannsheil Bochum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
aseptic distal femoral nonunion on admission to our hospital, an intact in situ lateral plate construct and an index procedure performed at our institution.
Exclusion Criteria
age under 18 years
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main outcome measurement is bony healing, Bony healing was radiologically defined as bridging bone on at least three visible cortices or an evident callus bridge spanning the nonunion zone. <br>Three observers independently evaluated the radiographs. The outcome measures of each patient were assessed at the final follow-up. The clinical follow-up assessments were done at regularly scheduled visits to our outpatient clinic and included a radiographic examination with anteroposterior and lateral radiographs, and a physical assessment of the affected limb.<br><br><br>
- Secondary Outcome Measures
Name Time Method The secondary outcome measures were index procedure-associated complications, i.e., the presence of persistent femoral nonunion without any signs of ongoing osseous healing within the first twelve months after the index procedure, and infection. The definition of an index procedure-associated infection was based on the consensus definition of the AO Foundation and the European Bone and Joint Infection Society. Soft tissue problems, i.e., wound breakdown and the presence of a sinus tract, in conjunction with clinical signs of infection, such as local pain, erythema, warmth and swelling in the affected limb, were counted as index procedure-associated infections regardless of whether the soft tissue samples of the index procedure tested positive for microorganisms.