Total Knee ReplacementNCT03502382
Prediction of Leg Length Discrepancy After Unilateral Total Knee Replacement in Varus Deformity
A study testing x-ray in people with Total Knee Replacement, run by Assiut University at 1 site in Egypt.
Trial summary
To What degree total knee replacement (TKA) affects leg length discrepancy in patients with varus deformity? Varus deformity, the most commonly encountered deformity in patients undergoing TKA is associated with limb alignment and varying degrees of contractures of medial soft tissue structures, laxity of the lateral… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- x-ray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 30 Apr 2019
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1-Cases of osteoarthritis of the knee with varus deformity undergoing unilateral TKA.
- 2-Cases with previous unilateral TKA undergoing TKA of the other side.
Who cannot join
- 1-Cases of osteoarthritis of the knee with valgus deformity. 2-Revision total knee replacement cases. 3-Patients with total hip replacement. 4-Extra-articular lower limb deformities. 5-Cases of bilateral TKA done at same setting. 6-Patients with previous knee surgery. 7-Patients with complicated inrta-operative TKA .
Trial locations and contacts
1 site in 1 country.
About this study
To What degree total knee replacement (TKA) affects leg length discrepancy in patients with varus deformity? Varus deformity, the most commonly encountered deformity in patients undergoing TKA is associated with limb alignment and varying degrees of contractures of medial soft tissue structures, laxity of the lateral soft tissue structures, flexion deformity and medial bone erosion at the knee joint .The challenges in performing TKA in a varus arthritic knee include restoration of limb alignment, balancing the medial and lateral soft tissue tension, equalizing flexion and extension gaps and restoring medial bone loss
Read the detailed description
Limb length discrepancy (LLD)less than 2cm is usually not noticeable and does not require treatment. LLD over 2cm is usually noticed by the individual affected leading to self compensation by walking on the ball of the foot (toe down) or by tilting the pelvis and curving the spine.Untreated LLD can lead to lower back pain and long leg arthritis of the hip LLD and its effects on patient function have been discussed in depth in the literature with respect to hip arthroplasty but there are few studies that have examined the effect on function of limb length discrepancy following TKA.
Improved surgical techniques and rehabilitation protocols have resulted in excellent knee function and range of motion following TKA.
The investigators are aiming from the study to improve functional outcome in patients with knee osteoarthritis undergoing TKA.
- Conditions
- Total Knee Replacement
- Being tested
- x-ray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
x-rayDiagnostic test
Radiological: standing antero-posterior full-length digital images of the lower extremities
| Study group | Role | What they receive |
|---|---|---|
| radilogical | Other | Radiological: standing antero-posterior full-length digital images of the lower extremities Receives: Diagnostic Test: x-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring ofleg length discrepancy before and after unilateral totalknee replacement.
Measuring ofleg length discrepancy before and after unilateral totalknee replacement.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start1 Apr 2018
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Cases of osteoarthritis of the knee with varus deformity undergoing unilateral TKA.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abanoub Nagaty Wahba, Assiut University
- Investigators
- Ahmed Abdel-Aal, prof., Study chair, prof. of orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502382
- Sponsor's protocol ID
- assiut university medical
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2018
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the results
Publications
Khalifa AA, Mullaji AB, Gendy AN, Ahmed AM, Bakr HM, Khalifa YE, Abdelaal AM. Prediction of leg length change (LLC) after correcting varus and flexion deformity in patients undergoing TKA. Eur J Orthop Surg Traumatol. 2021 Aug;31(6):1199-1205. doi: 10.1007/s00590-020-02853-6. Epub 2021 Jan 9.
PubMed 33423113
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Leg Length Discrepancy After Unilateral Total Knee Replacement in Varus Deformity
- ClinicalTrials.gov ID
- NCT03502382
- Acronym / sponsor ID
- assiut university medical
- Conditions
- Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 18 Apr 2018 (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.
To What degree total knee replacement (TKA) affects leg length discrepancy in patients with varus deformity? Varus deformity, the most commonly encountered deformity in patients undergoing TKA is associated with limb alignment and varying degrees of contractures of medial soft tissue structures, laxity of the lateral soft tissue structures, flexion deformity and medial bone erosion at the knee joint .The challenges in performing TKA in a varus arthritic knee include restoration of limb alignment, balancing the medial and lateral soft tissue tension, equalizing flexion and extension gaps and restoring medial bone loss
Detailed description
Limb length discrepancy (LLD)less than 2cm is usually not noticeable and does not require treatment. LLD over 2cm is usually noticed by the individual affected leading to self compensation by walking on the ball of the foot (toe down) or by tilting the pelvis and curving the spine.Untreated LLD can lead to lower back pain and long leg arthritis of the hip LLD and its effects on patient function have been discussed in depth in the literature with respect to hip arthroplasty but there are few studies that have examined the effect on function of limb length discrepancy following TKA.
Improved surgical techniques and rehabilitation protocols have resulted in excellent knee function and range of motion following TKA.
The investigators are aiming from the study to improve functional outcome in patients with knee osteoarthritis undergoing TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cases of osteoarthritis of the knee with varus deformity undergoing unilateral TKA.
| Arm | Type | Receives |
|---|---|---|
| radilogical | Other | Diagnostic Test: x-rayRadiological: standing antero-posterior full-length digital images of the lower extremities |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 1-Cases of osteoarthritis of the knee with varus deformity undergoing unilateral TKA.
- 2-Cases with previous unilateral TKA undergoing TKA of the other side.
Key exclusion criteria (1 listed)
- 1-Cases of osteoarthritis of the knee with valgus deformity. 2-Revision total knee replacement cases. 3-Patients with total hip replacement. 4-Extra-articular lower limb deformities. 5-Cases of bilateral TKA done at same setting. 6-Patients with previous knee surgery. 7-Patients with complicated inrta-operative TKA .
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 |
|---|---|---|
| x-rayRadiological: standing antero-posterior full-length digital images of the lower extremities | Diagnostic test | radilogical |
Primary outcome
Measuring ofleg length discrepancy before and after unilateral totalknee replacement.
Time frame: 1 day
Measuring ofleg length discrepancy before and after unilateral totalknee replacement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Derived from this study: PubMed 33423113Khalifa AA, Mullaji AB, Gendy AN, Ahmed AM, Bakr HM, Khalifa YE, Abdelaal AM. Prediction of leg length change (LLC) after correcting varus and flexion deformity in patients undergoing TKA. Eur J Orthop Surg Traumatol. 2021 Aug;31(6):1199-1205. doi: 10.1007/s00590-020-02853-6. Epub 2021 Jan 9.
- 1\. MihalkoWM, Saleh KJ, Krackow KA, Whiteside LA. Soft-tissue balancing during total knee arthroplasty in the varus knee. J Am Acad Orthop Surg. 2009;17:766-74.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. the results
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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 Abdel-Aal, prof. study chair
prof. of orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing x-ray in people with Total Knee Replacement, run by Assiut University 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 2 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 19 Apr 2018. 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?
Results are not available in the source record.
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?
Measuring ofleg length discrepancy before and after unilateral totalknee replacement. (time frame: 1 day). 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 NCT03502382, which also lists 1 linked publication.
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 19 Apr 2018.