Amputation of KneeNCT06365203
Comparative Study of Through Knee Amputation Versus Above Knee Amputation Regarding Infection Rate and Function
A study testing Through knee amputation and Above knee Amputation in people with Amputation of Knee, run by Assiut University.
Trial summary
The aim of this study is to search and compare outcomes of through knee amputation (TKA) and above knee amputation (AKA) in terms of Technique ,wound healing ,infection rate , function and ambulation Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amputation of Knee
- What is being tested?
- Through knee amputation and Above knee Amputation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Apr 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Critical limb ischemia with sever infection with no role For BKA
- Acute late or total ischemia SFA with poor
- popliteal signals and no distal run off
- Infected Diabetic foot (DF) affecting heel and calf muscle with preserved knee joint
- Traumatic gangrene
Who cannot join
- Venous gangrene
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to search and compare outcomes of through knee amputation (TKA) and above knee amputation (AKA) in terms of Technique ,wound healing ,infection rate , function and ambulation
Read the detailed description
Severe peripheral arterial disease with or without comorbid diabetes mellitus accounts for the majority of patients requiring major lower extremity amputations.
There is also an association between major extremity amputation and lower socio-economic status, attributed to lifestyle and comorbidities, living and working conditions, psychosocial factors, and access to affordable healthcare.
With a transfemoral prosthesis, the amputee weight bears through their ischial tuberosity which can cause discomfort when standing or ambulating. These challenges have been associated with greater abandonment of prosthesis use. An often over looked alternative within amputation surgery is through knee amputation (TKA), which currently comprises less than 5% of all major lower extremity amputations.
Compared with AKA, TKA is a less traumatic procedure with little disruption to thigh muscles, articular cartilage, menisci, and bone (especially with Knee Disarticulation), which in turn reduces post-operative infection and formation of bone spurs.
In contrast, AKA can also provide additional problems. Due to a shorter lever length of the residuum, the unilateral transfemoral amputee requires three times more energy to ambulate with a prosthetic limb compared with a unilateral transtibial amputee.
Among vascular surgeons, TKA is similarly rarely performed. Fear of poor wound healing and potential stump breakdown in longer soft tissue flaps needed to cover epicondyles of the distal femur are possible preconceived misconceptions. Historically, outcomes after TKA are acceptable, but scarce vascular literature exists reporting contemporary outcomes of TKA.
- Conditions
- Amputation of Knee
- Being tested
- Through knee amputation, Above knee Amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Through knee amputationProcedure or surgery
Amputation Technique
Above knee AmputationProcedure or surgery
Amputation Technique
| Study group | Role | What they receive |
|---|---|---|
| Through knee amputation | Active comparator | Through knee amputation Receives: Procedure: Through knee amputation; Procedure: Above knee Amputation |
| Above knee Amputation | Active comparator | Above knee Amputation Receives: Procedure: Through knee amputation; Procedure: Above knee Amputation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing rate
Rates of healing of different amputees
Measured: One year
Incidence of infection
Measured: One year
Secondary outcomes (2)
Function of the limb Rehabilitation Quality of life
Incidence of recurrence
Measured: Two years
Mortality rate
Measured: Tow years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Amputation of KneeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Adly Omar, Assiut University
- Investigators
- Ahmed Mu Nagy, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365203
- Sponsor's protocol ID
- Through knee amputation
- Status last verified
- Apr 2024
- First submitted
- 22 Mar 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.
PubMed 18295618Kolossvary E, Farkas K, Karahan O, Golledge J, Schernthaner GH, Karplus T, Bernardo JJ, Marschang S, Abola MT, Heinzmann M, Edmonds M, Catalano M. The importance of socio-economic determinants of health in the care of patients with peripheral artery disease: A narrative review from VAS. Vasc Med. 2023 Jun;28(3):241-253. doi: 10.1177/1358863X231169316. Epub 2023 May 8.
PubMed 37154387Panhelleux B, Shalhoub J, Silverman AK, McGregor AH. A review of through-knee amputation. Vascular. 2022 Dec;30(6):1149-1159. doi: 10.1177/17085381211045183. Epub 2021 Nov 29.
PubMed 34844469Crane H, Boam G, Carradice D, Vanicek N, Twiddy M, Smith GE. Through-knee versus above-knee amputation for vascular and non-vascular major lower limb amputations. Cochrane Database Syst Rev. 2021 Dec 14;12(12):CD013839. doi: 10.1002/14651858.CD013839.pub2.
PubMed 34904714Howard RR, Chamberlain J, Macpherson AI. Through-knee amputation in peripheral vascular disease. Lancet. 1969 Aug 2;2(7614):240-2. doi: 10.1016/s0140-6736(69)90007-5. No abstract available.
PubMed 4184110Cull DL, Taylor SM, Hamontree SE, Langan EM, Snyder BA, Sullivan TM, Youkey JR. A reappraisal of a modified through-knee amputation in patients with peripheral vascular disease. Am J Surg. 2001 Jul;182(1):44-8. doi: 10.1016/s0002-9610(01)00663-8.
PubMed 11532414
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Through Knee Amputation Versus Above Knee Amputation Regarding Infection Rate and Function
- ClinicalTrials.gov ID
- NCT06365203
- Acronym / sponsor ID
- Through knee amputation
- Conditions
- Amputation of Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 15 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.
The aim of this study is to search and compare outcomes of through knee amputation (TKA) and above knee amputation (AKA) in terms of Technique ,wound healing ,infection rate , function and ambulation
Detailed description
Severe peripheral arterial disease with or without comorbid diabetes mellitus accounts for the majority of patients requiring major lower extremity amputations.
There is also an association between major extremity amputation and lower socio-economic status, attributed to lifestyle and comorbidities, living and working conditions, psychosocial factors, and access to affordable healthcare.
With a transfemoral prosthesis, the amputee weight bears through their ischial tuberosity which can cause discomfort when standing or ambulating. These challenges have been associated with greater abandonment of prosthesis use. An often over looked alternative within amputation surgery is through knee amputation (TKA), which currently comprises less than 5% of all major lower extremity amputations.
Compared with AKA, TKA is a less traumatic procedure with little disruption to thigh muscles, articular cartilage, menisci, and bone (especially with Knee Disarticulation), which in turn reduces post-operative infection and formation of bone spurs.
In contrast, AKA can also provide additional problems. Due to a shorter lever length of the residuum, the unilateral transfemoral amputee requires three times more energy to ambulate with a prosthetic limb compared with a unilateral transtibial amputee.
Among vascular surgeons, TKA is similarly rarely performed. Fear of poor wound healing and potential stump breakdown in longer soft tissue flaps needed to cover epicondyles of the distal femur are possible preconceived misconceptions. Historically, outcomes after TKA are acceptable, but scarce vascular literature exists reporting contemporary outcomes of TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Through knee amputation | Active comparator | Procedure: Through knee amputation, Procedure: Above knee AmputationThrough knee amputation |
| Above knee Amputation | Active comparator | Procedure: Through knee amputation, Procedure: Above knee AmputationAbove knee Amputation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Critical limb ischemia with sever infection with no role For BKA
- Acute late or total ischemia SFA with poor
- popliteal signals and no distal run off
- Infected Diabetic foot (DF) affecting heel and calf muscle with preserved knee joint
- Traumatic gangrene
Key exclusion criteria (1 listed)
- Venous gangrene
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 |
|---|---|---|
| Through knee amputationAmputation Technique | Procedure or surgery | Above knee Amputation, Through knee amputation |
| Above knee AmputationAmputation Technique | Procedure or surgery | Above knee Amputation, Through knee amputation |
Primary outcome
Wound healing rate
Time frame: One year
Rates of healing of different amputees
Incidence of infection
Time frame: One year
2 secondary outcomes
Function of the limb Rehabilitation Quality of life
Time frame: Two years
Mortality rate
Time frame: Tow years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Background: PubMed 18295618Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.
- Background: PubMed 37154387Kolossvary E, Farkas K, Karahan O, Golledge J, Schernthaner GH, Karplus T, Bernardo JJ, Marschang S, Abola MT, Heinzmann M, Edmonds M, Catalano M. The importance of socio-economic determinants of health in the care of patients with peripheral artery disease: A narrative review from VAS. Vasc Med. 2023 Jun;28(3):241-253. doi: 10.1177/1358863X231169316. Epub 2023 May 8.
- Background: PubMed 34844469Panhelleux B, Shalhoub J, Silverman AK, McGregor AH. A review of through-knee amputation. Vascular. 2022 Dec;30(6):1149-1159. doi: 10.1177/17085381211045183. Epub 2021 Nov 29.
- Background: PubMed 34904714Crane H, Boam G, Carradice D, Vanicek N, Twiddy M, Smith GE. Through-knee versus above-knee amputation for vascular and non-vascular major lower limb amputations. Cochrane Database Syst Rev. 2021 Dec 14;12(12):CD013839. doi: 10.1002/14651858.CD013839.pub2.
- Background: PubMed 4184110Howard RR, Chamberlain J, Macpherson AI. Through-knee amputation in peripheral vascular disease. Lancet. 1969 Aug 2;2(7614):240-2. doi: 10.1016/s0140-6736(69)90007-5. No abstract available.
- Background: PubMed 11532414Cull DL, Taylor SM, Hamontree SE, Langan EM, Snyder BA, Sullivan TM, Youkey JR. A reappraisal of a modified through-knee amputation in patients with peripheral vascular disease. Am J Surg. 2001 Jul;182(1):44-8. doi: 10.1016/s0002-9610(01)00663-8.
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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.
Ahmed Mu Nagy study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Through knee amputation and Above knee Amputation in people with Amputation of Knee, run by Assiut University.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Mo Adly, Resident (+201553287304, aadly1098@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing rate (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06365203, which also lists 6 linked publications.
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 15 Apr 2024.