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

Proximal Femur Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06360835
• Other study ID #: IRB00001193
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: December 2, 2021

Study information

• Verified date: April 2024
• Source: Ibn Jazzar Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Proximal Femur Fractures

Intervention

Procedure:
• total hip arthroplasty

Locations

Country	Name	City	State
Tunisia	IBN jazzar hospital	Kairouan

Sponsors (1)

Lead Sponsor	Collaborator
Ibn Jazzar Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Approach	type of approach	from enrollment to the of treatment 6 years
Primary	Preparation of the Patient	type of preparation	from enrollment to the of treatment 6 years
Primary	Anesthesia	type of anesthesia	from enrollment to the of treatment 6 years
Primary	Type of Surgical Revision	material implanted for revision	from enrollment to the of treatment 6 years
Primary	Types of Prosthesis	prothesis used	from enrollment to the of treatment 6 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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