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The Clinical Results of Dual Plate versus Exchange Nailing with Augmentation Plating for Complicated Femoral Shaft Nonunion.

The Clinical Results of Dual Plate versus Exchange Nailing with Augmentation Plating for Complicated Femoral Shaft Nonunion.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ORC-17014062
Enrollment
Unknown
Registered
2017-12-20
Start date
2018-01-01
Completion date
Unknown
Last updated
2018-01-29

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

Conditions

complicated femoral shaft nonunion after surgery

Interventions

Experimental group:exchange nailing with augmentation plating
control group:dual plating

Sponsors

General Hospital of PLA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All of the following criteria must be met at the same time to enter the study: 1. The definition of the nonunion is that: patients whose fracture did not heal for at least 9 months since the fixation of the fracture and whose continuous imaging observations in the recent 3 months did not show any progress in fracture healing; 2. According to OTA classification, the definition of the femoral shaft is that: the transverse lower edge of the lesser trochanter to the upper border of the transepicondylar width of the knee; 3. aseptic nonunion:negative inflammatory markers and physical examination preoperatively and negative bacterial culture postoperatively; 4. aged older than 18 years; On the basis of all the above conditions, one of the following conditions is finally included in the study: 1. primary interanl device is broked after plating or nailing; 2. obvious nalformation: angulation >5 degree, or malrotation > 15 degree, or LLD (limb length discrepancy) > 2 cm; 3. bone defect 2 to 6cm.

Exclusion criteria

Exclusion criteria: 1. septic nonunion; 2. Pathological fracture nonunion; 3. without significant malformation which was defined as angulation <5°,malrotation < 15° LLD (limb length discrepancy) < 2 cm; 4. Poor compliance. 5. refuse to participate in the study.

Design outcomes

Primary

MeasureTime frame
Fracture healing time;rate of fracture healing;SF-36 score;

Secondary

MeasureTime frame
operation time;length of incision;blood loss;blood transfusion;knee range of motion;start time of weight bearing;time of fully weight bearing;Time to return to work;

Countries

China

Contacts

Public ContactPeifu Tang

Orthopedics department, General Hospital of PLA

pftang301@163.com+86 13801379901

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 4, 2026