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Completed

NCT Number: NCT06360835

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.

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Key information

Conditions

Proximal Femur Fractures Femoral Fractures Femoral Neck Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Proximal Femoral Fractures Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

IBN jazzar hospital

Kairouan, 3190, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Hip Arthroplasty

Procedure

Other names: plate, dynamic condylar screw

Primary outcomes

  1. Surgical Approach

    Time frame: from enrollment to the of treatment 6 years

    type of approach

  2. Preparation of the Patient

    Time frame: from enrollment to the of treatment 6 years

    type of preparation

  3. Anesthesia

    Time frame: from enrollment to the of treatment 6 years

    type of anesthesia

  4. Type of Surgical Revision

    Time frame: from enrollment to the of treatment 6 years

    material implanted for revision

  5. Types of Prosthesis

    Time frame: from enrollment to the of treatment 6 years

    prothesis used

Secondary outcomes

  1. Age Distribution

    Time frame: from enrollment to the end of treatment 6 years

    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.

  2. Distribution by Sex

    Time frame: from enrollment to the end of treatment 6 years

    Females represented a slight majority in the study, accounting for 57% (20 women), while males comprised 43% (15 men).

  3. Distribution According to Affected Side

    Time frame: from enrollment to the end of treatment 6 years

    The right side was affected in 60% (21 cases), while the left side was affected in 40% (14 cases).

  4. Distribution According to Circumstances of Trauma

    Time frame: from enrollment to the end of treatment 6 years

    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.

Sponsors and collaborators

Lead sponsor

Ibn Jazzar Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Apr 11, 2024
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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