search
Back to results

Prediction of Leg Length Discrepancy After Unilateral Total Knee Replacement in Varus Deformity

Primary Purpose

Total Knee Replacement

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
x-ray
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Knee Replacement

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- 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.

Exclusion Criteria:

  • 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 .

Sites / Locations

  • Assiut University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

radilogical

Arm Description

Radiological: standing antero-posterior full-length digital images of the lower extremities

Outcomes

Primary Outcome Measures

Measuring ofleg length discrepancy before and after unilateral totalknee replacement.
Measuring ofleg length discrepancy before and after unilateral totalknee replacement.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2018
Last Updated
April 17, 2018
Sponsor
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT03502382
Brief Title
Prediction of Leg Length Discrepancy After Unilateral Total Knee Replacement in Varus Deformity
Official Title
Prediction of Leg Length Discrepancy After Unilateral Total Knee Replacement in Varus Deformity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Anticipated)
Study Completion Date
April 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cases of osteoarthritis of the knee with varus deformity undergoing unilateral TKA.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
radilogical
Arm Type
Other
Arm Description
Radiological: standing antero-posterior full-length digital images of the lower extremities
Intervention Type
Diagnostic Test
Intervention Name(s)
x-ray
Intervention Description
Radiological: standing antero-posterior full-length digital images of the lower extremities
Primary Outcome Measure Information:
Title
Measuring ofleg length discrepancy before and after unilateral totalknee replacement.
Description
Measuring ofleg length discrepancy before and after unilateral totalknee replacement.
Time Frame
1 day

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - 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. Exclusion Criteria: 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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdel-Aal, prof.
Organizational Affiliation
prof. of orthopaedics
Official's Role
Study Chair
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
088
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
the results
Citations:
PubMed Identifier
33423113
Citation
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.
Results Reference
derived
Links:
URL
https://pdfs.semanticscholar.org/26de/363e5af4230cb80e7146ea7cfb0baad14b85.pdf
Description
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.

Learn more about this trial

Prediction of Leg Length Discrepancy After Unilateral Total Knee Replacement in Varus Deformity

We'll reach out to this number within 24 hrs