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

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.

Study Overview

• Status: Completed
• Conditions: Proximal Femur Fractures
• Intervention / Treatment: Procedure: total hip arthroplasty

Detailed Description

The aim was to identify the causes of mechanical failures of osteosynthesis in order to prevent them. Methods: We present the experience of the Department of Surgical Orthopedic Surgery, concerning 35 cases summarized after failure of surgical treatment of a fracture of the proximal end of the femur for a period spreading between January 2015 and December 2021. . The literature already found evidence of the greater complexity of this type of procedure compared to a first-line total hip prosthesis. Accordingly, all this, Prevention is better than cure these stiffnesses through good preoperative planning. Other factors related to the terrain or to untimely loading of the implant are more difficult to control. Whatever the cause, the surgeon remains by the rigor in these indications, the choice of the synthetic material the essential element in the prevention of osteosynthesis failures.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Tunisia
  • Kairouan, Tunisia, 3190
    • IBN jazzar hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• • Diagnosis of a fracture of the proximal end of the femur.

  • Subsequent surgical intervention(s) due to failure of initial surgical treatment

Exclusion Criteria:

• • 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cases of recurrent fractures of the proximal end of the femur following surgical treatment failure	Procedure: total hip arthroplasty; Other Names: plate; dynamic condylar screw

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age Distribution	The average age of patients experiencing therapeutic failure after surgical treatment of proximal femur fractures was 66 years, with ages ranging from 28 to 94 years. The age group 50-90 years constituted 68.59% of cases.	from enrollment to the end of treatment 6 years
Distribution by Sex	Females represented a slight majority in the study, accounting for 57% (20 women), while males comprised 43% (15 men).	from enrollment to the end of treatment 6 years
Distribution According to Affected Side	The right side was affected in 60% (21 cases), while the left side was affected in 40% (14 cases).	from enrollment to the end of treatment 6 years
Distribution According to Circumstances of Trauma	Fractures were predominantly due to minimal trauma, with rare occurrences related to road accidents or domestic falls, attributed to bone fragility and muscle atrophy. One case of a pathological fracture was observed in a patient with dislocation of an intermediate hip prosthesis due to ovarian cancer.	from enrollment to the end of treatment 6 years

Collaborators and Investigators

• Sponsor: Ibn Jazzar Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 2, 2021

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pertrochanteric fracture; femoral neck fracture; internal osteosynthesis; mechanical complications
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: IRB00001193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: use for other resaerchs

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No