Distal Femur FractureNCT05363943
DP Vs DFR for Management of Geriatric Distal Femur Fractures.
A study testing double plating and Distal femoral replacement in people with Distal Femur Fracture and Geriatrics, run by Amr Gamaleldin Mahmoud Khalil Gendya at 1 site in Egypt.
Trial summary
The aim of this study was to compare the functional and radiological outcomes of fixation by using double plating technique versus replacement using distal femur tumor prothesis as a primary management for the distal femoral fractures in geriatric patients. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Distal Femur Fracture, Geriatrics
- What is being tested?
- double plating and Distal femoral replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2018to 31 Dec 2021
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AO 33 A3 and 33 C fractures
- Age group ≥ 60 years
- Closed fractures
- Neurovascular intact
Who cannot join
- Open fractures
- Non ambulant patients
- Patients with peripheral neurovascular diseases
- Peri-prosthetic fractures
- Associated other orthopedic injuries
- Poly-traumatized patients
- Pathological fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Plating (DP) Fixation vs Distal Femoral Replacement (DFR) in the Management of Distal Femoral Fractures in Geriatric Patients.
The aim of this study was to compare the functional and radiological outcomes of fixation by using double plating technique versus replacement using distal femur tumor prothesis as a primary management for the distal femoral fractures in geriatric patients. The hypothesis was that the distal femoral replacement will yield better functional outcome and earlier rehabilitation and return to pre-injury level of activity.
Read the detailed description
Geriatric distal femoral fractures represent a major challenge for the orthopedic surgeons, to the present days still there is no definite algorithm or specific guidelines that can be used accurately in the management of these fractures. Unlike hip fractures however, there is no widely accepted treatment algorithm or standard of care.
The surgical treatment of distal femoral fractures depends on both patient and fracture characteristics. Options include conservative treatment, open reduction internal fixation, intramedullary nails, or recently distal femoral replacement.
There is currently a move towards distal femoral replacement (DFR) for these complex fractures which has the potential benefit of allowing early weight bearing, and therefore aiming to prevent complications associated with immobility and non-union.
Using distal femoral replacement had yield good results in small case series, as it allows immediate full weightbearing, eliminate the risk of nonunion and may provide greater satisfaction scores. However, DFR has its own risks, most notably deep infection, and loosening. While a DFR is more costly compared with fixation plates and nails, the initial increased cost may be outweighed by faster rehabilitation and return to the patient's usual place of residence.
In the study, the investigators are aiming to compare the functional and radiological outcomes of fixation by using double plating technique versus replacement as a primary management for the geriatric distal femoral fractures.
- Conditions
- Distal Femur Fracture, Geriatrics
- Being tested
- double plating, Distal femoral replacement
- Keywords
- Distal femoral fractures, Double plating, Distal femoral replacement, Geriatrics
- Medical subject headings
- Femoral Fractures, Distal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double platingProcedure or surgery
open reduction and internal fixation by using lateral and medial plates.
Distal femoral replacementProcedure or surgery
excision of the distal part of femur and replacement with distal femoral prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Fixation | Active comparator | open reduction and internal fixation by using lateral and medial plates. Receives: Procedure: double plating |
| Replacement | Experimental | excision of the distal part of femur and replacement with distal femoral prosthesis Receives: Procedure: Distal femoral replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Knee Society Score
the score has two-part, knee and function parts. The score is graded from 0 to 100 in each domain with 100 is the best outcome and 0 is the worst. The knee part assesses the range of motion, pain, and alignment of the joint while the function part assesses walking, stairs and usage of walking aids.
Measured: 1 month, 6 month and 12 month
Secondary outcomes (4)
change in Knee range of motion
Assessment of range of motion of the knee which has normal range from 0 to 135
Measured: 1 month and 12 month
Postoperative complications
Assessment of postoperative complications either early or late complications
Measured: form first day to 12 month
Reoperation rate
Recording the need for secondary operation for a cause related to the fracture union, postoperative complications, or prothesis problems.
Measured: form first day to 12 month
Operative time
Recording of the operative time from the time of incision to the time of skin closure
Measured: At the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start20 Aug 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Femur FractureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amr Gamaleldin Mahmoud Khalil Gendya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amr Gamaleldin Mahmoud Khalil Gendya, Ain Shams University
- Investigators
- Amr GM Gendya, MSc Ortho., Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363943
- Sponsor's protocol ID
- FMASU MD 291/2019
- Status last verified
- Jul 2023
- First submitted
- 27 Apr 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Plating (DP) Fixation vs Distal Femoral Replacement (DFR) in the Management of Distal Femoral Fractures in Geriatric Patients.
- ClinicalTrials.gov ID
- NCT05363943
- Acronym / sponsor ID
- FMASU MD 291/2019
- Conditions
- Distal Femur Fracture, Geriatrics
- Keywords
- Distal femoral fractures, Double plating, Distal femoral replacement, Geriatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Amr Gamaleldin Mahmoud Khalil GendyaUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 May 2022 (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.
The aim of this study was to compare the functional and radiological outcomes of fixation by using double plating technique versus replacement using distal femur tumor prothesis as a primary management for the distal femoral fractures in geriatric patients. The hypothesis was that the distal femoral replacement will yield better functional outcome and earlier rehabilitation and return to pre-injury level of activity.
Detailed description
Geriatric distal femoral fractures represent a major challenge for the orthopedic surgeons, to the present days still there is no definite algorithm or specific guidelines that can be used accurately in the management of these fractures. Unlike hip fractures however, there is no widely accepted treatment algorithm or standard of care.
The surgical treatment of distal femoral fractures depends on both patient and fracture characteristics. Options include conservative treatment, open reduction internal fixation, intramedullary nails, or recently distal femoral replacement.
There is currently a move towards distal femoral replacement (DFR) for these complex fractures which has the potential benefit of allowing early weight bearing, and therefore aiming to prevent complications associated with immobility and non-union.
Using distal femoral replacement had yield good results in small case series, as it allows immediate full weightbearing, eliminate the risk of nonunion and may provide greater satisfaction scores. However, DFR has its own risks, most notably deep infection, and loosening. While a DFR is more costly compared with fixation plates and nails, the initial increased cost may be outweighed by faster rehabilitation and return to the patient's usual place of residence.
In the study, the investigators are aiming to compare the functional and radiological outcomes of fixation by using double plating technique versus replacement as a primary management for the geriatric distal femoral fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixation | Active comparator | Procedure: double platingopen reduction and internal fixation by using lateral and medial plates. |
| Replacement | Experimental | Procedure: Distal femoral replacementexcision of the distal part of femur and replacement with distal femoral prosthesis |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- AO 33 A3 and 33 C fractures
- Age group ≥ 60 years
- Closed fractures
- Neurovascular intact
Key exclusion criteria (7 listed)
- Open fractures
- Non ambulant patients
- Patients with peripheral neurovascular diseases
- Peri-prosthetic fractures
- Associated other orthopedic injuries
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 |
|---|---|---|
| double platingopen reduction and internal fixation by using lateral and medial plates. | Procedure or surgery | Fixation |
| Distal femoral replacementexcision of the distal part of femur and replacement with distal femoral prosthesis | Procedure or surgery | Replacement |
Primary outcome
change in Knee Society Score
Time frame: 1 month, 6 month and 12 month
the score has two-part, knee and function parts. The score is graded from 0 to 100 in each domain with 100 is the best outcome and 0 is the worst. The knee part assesses the range of motion, pain, and alignment of the joint while the function part assesses walking, stairs and usage of walking aids.
4 secondary outcomes
change in Knee range of motion
Time frame: 1 month and 12 month
Postoperative complications
Time frame: form first day to 12 month
Reoperation rate
Time frame: form first day to 12 month
Operative time
Time frame: At the operation
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 20 Jul 2023.
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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.
Amr GM Gendya, MSc Ortho. principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing double plating and Distal femoral replacement in people with Distal Femur Fracture and Geriatrics, run by Amr Gamaleldin Mahmoud Khalil Gendya at 1 site in Egypt.
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 4 inclusion and 7 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 20 Jul 2023. 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 Egypt. 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?
change in Knee Society Score (time frame: 1 month, 6 month and 12 month). 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 20 Jul 2023.