Our Experience in the Management of Therapeutic Failures of Fractures of the Proximal End of the Femur (About 35 Cases)

NCT06360835 | Completed

• 1 other identifier: IRB00001193
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Osteosyntheses employed in treating fractures at the upper end of the femur play a critical role in facilitating a swift recovery by minimizing immobilization periods and enabling early rehabilitation of the affected joints, thereby promoting a speedy return to normal walking function. Osteosynthesis alters the mechanical dynamics of the bone segment, which undergoes continual changes during the consolidation and mobilization phases of recovery. Throughout these stages, a range of mechanical complications may arise, posing challenges despite the successful prevention of infections. Non-infectious complications associated with the presence of osteosynthesis materials, especially in weight-bearing areas like the lower limb, remain a concern. In light of these considerations, surgeons must exercise meticulous care in selecting synthetic materials to mitigate the risk of osteosynthesis failures. In cases where internal fixation fails, the standard recourse often involves converting to total hip arthroplasty (THA). However, it is essential to note that THA subsequent to complications arising from proximal femur osteosynthesis presents a higher incidence of both intraoperative and postoperative complications compared to the implantation of primary total hip prostheses. Thus, while osteosynthesis remains a valuable intervention for femur fractures, careful attention to material selection and postoperative management is crucial in optimizing patient outcomes and minimizing complications.

Conditions

Proximal Femur Fractures

Keywords

femoral neck fracture; pertrochanteric fracture; internal osteosynthesis; mechanical complications

Outcome Measures

Primary Outcomes (5)

• Surgical Approach

  type of approach

  from enrollment to the of treatment 6 years

• Preparation of the Patient

  type of preparation

  from enrollment to the of treatment 6 years

• Anesthesia

  type of anesthesia

  from enrollment to the of treatment 6 years

• Type of Surgical Revision

  material implanted for revision

  from enrollment to the of treatment 6 years

• Types of Prosthesis

  prothesis used

  from enrollment to the of treatment 6 years

Secondary Outcomes (4)

• Age Distribution

  from enrollment to the end of treatment 6 years

• Distribution by Sex

  from enrollment to the end of treatment 6 years

• Distribution According to Affected Side

  from enrollment to the end of treatment 6 years

• Distribution According to Circumstances of Trauma

  from enrollment to the end of treatment 6 years

Study Arms (1)

cases of recurrent fractures of the proximal end of the femur following surgical treatment failure

Procedure: total hip arthroplasty

Interventions

total hip arthroplasty PROCEDURE

Also known as: plate, dynamic condylar screw

cases of recurrent fractures of the proximal end of the femur following surgical treatment failure

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

cases of recurrent fractures of the proximal end of the femur following surgical treatment failure

You may qualify if:

• Diagnosis of a fracture of the proximal end of the femur.
• Subsequent surgical intervention(s) due to failure of initial surgical treatment

You may not qualify if:

• Those initially treated with total hip arthroplasty.
• Patients lost to follow-up, not consistently monitored, or untreated after diagnosis of the complication.
• Cases with incomplete medical records

Sponsors & Collaborators

• Ibn Jazzar Hospital: lead

Study Sites (1)

IBN jazzar hospital

Kairouan, 3190, Tunisia

Location

MeSH Terms

Conditions

Proximal Femoral Fractures; Femoral Neck Fractures

Interventions

Arthroplasty, Replacement, Hip; Bone Plates

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 11, 2024
• Study Start: January 1, 2015
• Primary Completion: December 1, 2021
• Study Completion: December 2, 2021
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)