Does Capsulotomy in Closed Reduction of Femoral Neck Fractures Decrease Incidence of Avascular Necrosis?

Femoral Neck Fractures Clinical Trial

Official title:

Does Capsulotomy in Closed Reduction of Femoral Neck Fractures Decrease Incidence of Avascular Necrosis?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06436352
• Other study ID #: MD-143-2019
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: May 2024
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Femur's neck injuries are frequently encountered fractures. They are usually due to high energy or low energy indirect trauma. Healing of these fractures is usually hindered due to "avascular necrosis (AVN)" or "non-union" of the Femur's head. This study looks forward to investigating the impact of capsulotomy and internal fixation in lowering the incidence of complications and improving the functional outcomes.

Description:

Femoral neck fractures constitute a frequent orthopaedic, usually due to indirect assault. It primarily affects older people, with younger people accounting for barely 2 - 3%. Nevertheless, since transportation has recently advanced rapidly, high-energy trauma has become increasingly widespread. The prevalence of femur neck injuries among youth is likewise growing in hospitals by an estimated rate of about 6000 yearly. Hip blood supply is especially important while addressing femoral neck fractures. Blood supply emerges from the capsular, intramedullary, and the ligamentum teres vessels. In adults, capsular vessels provide most of the femur's head blood supply. The arteries originate out of the "medial and lateral circumflex femoral arteries". Those areteries are in turn branced out of the profunda femoris in seventy nine of the population. There is an exception for 20% of population where one vessel originates from the femoral artery. Moreover, there is 1% of the population in which both vessels originate from the femoral artery. The effectiveness and benefits of capsulotomy in treating femur's neck fractures among youth were compared to "closed reduction and internal fixation (CRIF)". AVN and non-union are the most prevalent and difficult complications. In terms of "trauma degree index" (incision length, amount of lost blood, and operative time), capsulotomy and internal fixation are less effective than CRIF. However, it outperforms CRIF in functional effectiveness (Harris Hip Score.

Some differences exist between capsulotomy reduction and internal fixation. First and foremost is proper anatomical reduction. With direct sight and adequate exposure, an acceptable anatomical reduction can be obtained, laying the groundwork for the healing of fractures. Furthermore, it could unlock certain retinacular arteries that have been temporarily blocked by kinking or stretching, allowing for the the restoration of some vascular function. The second principal is "stable internal fixation" that can be achieved by proper placement of the screws under direct visualization.

Researchers have concluded that evacuating of the hematoma significantly lowers the capsular pressure and improves pulse perfusion of the femur's head. Our study aims to investigate the efficiency of capsulotomy in enhancing the healing process of femur's neck fractures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Skeletally mature patients with fracture neck femur who will undergo urgent surgery within 48 hours.

• Male and female patients of any garden classification of femoral neck fractures

• within age group from 18 - 55 years

Exclusion Criteria:

• Patients of age below 18 years or above 55 years.

• those with metabolic bone disease, pathological fractures, stress fracture or delayed presentation more than 48 hours were excluded.

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone
• Necrosis

Intervention

Procedure:
• Capsulotomy and fixation
Firstly, Guide wire insertion passing anterior to the GT and the neck is done. then passing a pointed Schanze 5 or 6 ± scalpel, under X-ray in AP-lateral views until reaching the capsule (intra trochanteric line). Aspiration of hematoma with suction was done. Then we fix the fracture by proceeding with drilling over the wires using a "3.6 mm cannulated drill bit". Then, we place three "7.0 mm or 7.3 mm cannulated cancellous screws" over the wires. In younger patients with thick cancellous bone, a "cannulated tap" may be required to precut the thread. A washer may be used to prevent the screw head from penetrating the thin cortex.
• Fixation only
we fix the fracture by proceeding with drilling over the wires using a "3.6 mm cannulated drill bit". Then, we place three "7.0 mm or 7.3 mm cannulated cancellous screws" over the wires. In younger patients with thick cancellous bone, a "cannulated tap" may be required to precut the thread. A washer may be used to prevent the screw head from penetrating the thin cortex.

Locations

Country	Name	City	State
Egypt	Kasr Alainy Hospital - Faculty of Medicine - Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris hip score	The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.	6 months
Secondary	Intra-operative blood loss	in ml	during the operation