Medial Augmentation Plating of Aseptic Distal Femoral Nonunions.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031961

Enrollment

Registered

2023-06-19

Start date

2018-05-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M84.1

Interventions

Group 1: medial femoral augmentation plating : The index procedure included a medial approach to the distal femur, complete debridement of the nonunion site, bone grafting and medial augmentation plat

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: age under 18 years

Design outcomes

Primary

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Germany

Contacts

Public ContactSebastian Lotzien

Berufsgenossenschaftliches Universitätsklinkum Bergmannsheil Bochum

sebastian.lotzien@bergmannsheil.de+492343020

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026