NCT03502382

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

1.1 years

First QC Date

April 11, 2018

Last Update Submit

April 17, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Measuring ofleg length discrepancy before and after unilateral totalknee replacement.

    1 day

Study Arms (1)

radilogical

OTHER

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

Diagnostic Test: x-ray

Interventions

x-rayDIAGNOSTIC_TEST

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

radilogical

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- 1-Cases of osteoarthritis of the knee with varus deformity undergoing unilateral TKA.
  • Cases with previous unilateral TKA undergoing TKA of the other side.

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 088, Egypt

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Ahmed Abdel-Aal, prof.

    prof. of orthopaedics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Cases of osteoarthritis of the knee with varus deformity undergoing unilateral TKA.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr.

Study Record Dates

First Submitted

April 11, 2018

First Posted

April 18, 2018

Study Start

April 1, 2018

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

April 19, 2018

Record last verified: 2018-04

Locations