Proximal Femur FracturesNCT06360835
Our Experience in the Management of Therapeutic Failures of Fractures of the Proximal End of the Femur (About 35 Cases)
An observational study of Proximal Femur Fractures, run by Ibn Jazzar Hospital at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Proximal Femur Fractures
- What is being tested?
- total hip arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2015to 2 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: cases of recurrent fractures of the proximal end of the femur following surgical treatment failure
Who may be able to join
- • Diagnosis of a fracture of the proximal end of the femur.
- Subsequent surgical intervention(s) due to failure of initial surgical treatment
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Proximal Femur Fractures
- Being tested
- total hip arthroplasty
- Keywords
- femoral neck fracture, pertrochanteric fracture, internal osteosynthesis, mechanical complications
- Medical subject headings
- Proximal Femoral Fractures, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total hip arthroplastyProcedure or surgery
Also called plate, dynamic condylar screw
| Study group | Role | What they receive |
|---|---|---|
| cases of recurrent fractures of the proximal end of the femur following surgical treatment failure | Not described Receives: Procedure: total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Approach
type of approach
Measured: from enrollment to the of treatment 6 years
Preparation of the Patient
type of preparation
Measured: from enrollment to the of treatment 6 years
Anesthesia
type of anesthesia
Measured: from enrollment to the of treatment 6 years
Type of Surgical Revision
material implanted for revision
Measured: from enrollment to the of treatment 6 years
Types of Prosthesis
prothesis used
Measured: from enrollment to the of treatment 6 years
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: from enrollment to the end of treatment 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Jan 2015
- Primary completion1 Dec 2021
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Femur FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Jazzar Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zied Mansi, Ibn Jazzar Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360835
- Sponsor's protocol ID
- IRB00001193
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: use for other resaerchs
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Our Experience in the Management of Therapeutic Failures of Fractures of the Proximal End of the Femur (About 35 Cases)
- ClinicalTrials.gov ID
- NCT06360835
- Acronym / sponsor ID
- IRB00001193
- Conditions
- Proximal Femur Fractures
- Keywords
- femoral neck fracture, pertrochanteric fracture, internal osteosynthesis, mechanical complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ibn Jazzar HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cases of recurrent fractures of the proximal end of the femur following surgical treatment failure | – | Procedure: total hip arthroplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- cases of recurrent fractures of the proximal end of the femur following surgical treatment failure
Key inclusion criteria (2 listed)
- • Diagnosis of a fracture of the proximal end of the femur.
Key exclusion criteria (3 listed)
- • Those initially treated with total hip arthroplasty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total hip arthroplastyAlso: plate, dynamic condylar screw | Procedure or surgery | cases of recurrent fractures of the proximal end of the femur following surgical treatment failure |
Primary outcome
Surgical Approach
Time frame: from enrollment to the of treatment 6 years
type of approach
Preparation of the Patient
Time frame: from enrollment to the of treatment 6 years
type of preparation
Anesthesia
Time frame: from enrollment to the of treatment 6 years
type of anesthesia
Type of Surgical Revision
Time frame: from enrollment to the of treatment 6 years
material implanted for revision
Types of Prosthesis
Time frame: from enrollment to the of treatment 6 years
prothesis used
4 secondary outcomes
Age Distribution
Time frame: from enrollment to the end of treatment 6 years
Distribution by Sex
Time frame: from enrollment to the end of treatment 6 years
Distribution According to Affected Side
Time frame: from enrollment to the end of treatment 6 years
Distribution According to Circumstances of Trauma
Time frame: from enrollment to the end of treatment 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No. use for other resaerchs
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Femur Fractures, run by Ibn Jazzar Hospital at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Approach (time frame: from enrollment to the of treatment 6 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.