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Fracture healing with distal femoral titanum locking plates in patients with distal femoral fractures

A comparative study of distal femoral locking plates for the fixation of distal femoral fractures: Long working length versus short working length titanum locking plates.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001023145
Enrollment
76
Registered
2019-07-17
Start date
2019-08-31
Completion date
2022-10-20
Last updated
2023-08-07

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

Conditions

None listed

Brief summary

All the patients with distal femoral fractures be randomized into two groups i,e, group A(long working length) and group B(short working length) and operated.In the long working length plating all the combi screw holes overlying the fracture or comminution will be left empty plus two combi empty screw holes will be left proximal to the fracture in the intact bone.In the short working length no combi screw holes in the intact bone near the fracture on either will be left empty.We hypothesize that longer working length of a titanium locking plate has less nonunion and plate breakage rates.

Interventions

Brief name: Distal femoral locking plates used for the treatment of distal femoral fractures and applied in two modes: Long working length versus short working length. Materials: Titanium distal femoral locking plates will be applied through surgery. Procedures: Surgery: Application of locking plates to patients of distal femoral fractures under anaesthesia and tourniquet control through lateral thigh incision in group A(long working length) and group B(short working length) Who: The operating s

Brief name: Distal femoral locking plates used for the treatment of distal femoral fractures and applied in two modes: Long working length versus short working length. Materials: Titanium distal femoral locking plates will be applied through surgery. Procedures: Surgery: Application of locking plates to patients of distal femoral fractures under anaesthesia and tourniquet control through lateral thigh incision in group A(long working length) and group B(short working length) Who: The operating surgeon will have minimum of 5 years post graduate experience in Orthopaedics & Traumatology Mode of delivery: It will be face to face.All patients with distal femoral fractures will be admitted in hospital in Orthopaedics & Traumatology Unit as soon as they are presented to hospital for treatment.After informed written consent each patient will operated upon individually. Number of times: Each patient in each group will be operated upon only once initially.(only one session) The duration of surgery(session) will last for one and half hour to two hours approximately.After surgery each patient will be seen face to face every 4th week for the first three months and then every three months till two years.If any complications of surgery is reported in the follow up visits,it will be dealt with accordingly at that time. Location: The intervention(surgery) will be performed on patients in Hospital(Lady Reading Hospital, Peshawar,Pakistan),This hospital is the biggest hospital of the province with a very large catchment area and all patients of long bone fractures are initially brought here for treatment. personalised what: Patients of distal femoral fractures will be divided in two groups and operated upon with distal femoral locking plates applied in long working length or short working length mode. why: Variations in the working length of a titanium locking plate affect stiffness and interfragmentary movements of a fracture and its healing.We hypothesize that longer working length of a titanium locking plate has less nonunion and plate breakage rates when: As soon as the patients of distal femoral fractures are presented in hospital and they gave informed consent for surgery and participation in study, they will be operated upon. How this will occur: All patients of distal femoral fractures meeting the inclusion criteria presenting to hospital for treatment and willing for surgery will be enrollment in the study and will be operated in hospital. All the patients will be randomized into two groups i,e, group A(long working length) and group B(short working length). In the long working length plating all the combi screw holes overlying the fracture or comminution will be left empty plus two combi empty screw holes will be left proximal to the fracture in the intact bone.In the short working length no combi screw holes in the intact bone near the fracture will be left empty.

Sponsors

Dr.Faaiz Ali Shah
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

The following fracture types will be included(AO classification): • 33-A1=Extra-articular simple • 33-A2= Extra articular metaphyseal wedge • 33-A3= Extra articular metaphyseal complex Received within one week after sustaining the fracture

Exclusion criteria

Open fractures 2. Polytrauma patients with other fractures like ipsilateral tibia or proximal femur fractures 3.Pathological fractures 4.Previously surgically treated fractures 5.Neuro Vascular injury/DVT 6.Periprosthetic fractures

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 12, 2026