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

NCT ID: NCT06436352

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-02-01

Brief 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.

Detailed 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.

Conditions

Femoral Neck Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group I: cases with capsulotomy during fixation

before fixation, We perform a guide wire insertion passing anterior to the Greater Trochanter and the neck is done. then passing a pointed Schanz 5 or 6mm ± scalpel, under X-ray in AP-lateral views until reaching the capsule (intra trochanteric line). Aspiration of hematoma with suction was done.

Group Type: EXPERIMENTAL

Capsulotomy and fixation

Intervention Type: PROCEDURE

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.

Group II: cases without capsulotomy during fixation

we fix the fracture without capsulotomy

Group Type: ACTIVE_COMPARATOR

Fixation only

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Omar Sabry

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr Alainy Hospital - Faculty of Medicine - Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MD-143-2019

Identifier Type: -

Identifier Source: org_study_id