NCT06555055

Brief Summary

Total knee arthroplasty (TKA ) is the gold standard treatment for advanced knee osteoarthritis. only 85% (75% to 92%) of patients with total knee arthroplasty are satisfied with their operations and 30% develops patellofemoral complications. Numerous biomechanical studies suggest that patellofemoral tracking is not always restored to physiological values, because the prosthetic trochlea may differ from the native trochlea. no study has been con-ducted to investigate the thickness of the trochlear groove and its effect on the outcome of Total knee replacement (TKR), So many people has different measurements of trochlear thickness which may affect Patellofemoral joint (PFJ) so knowing of native trochlear thickness in patients with KNEE Osteoarthritis (OA) can affect the outcomes of total knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

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

September 30, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

1.6 years

First QC Date

July 14, 2024

Last Update Submit

August 13, 2024

Conditions

Keywords

Knee OsteoarthritispatellofemoralTKATrochlear thickness

Outcome Measures

Primary Outcomes (3)

  • Functional outcome

    knee society score (KSS).

    preoperative and six months postoperatively

  • Functional Outcome

    Patellofemoral score (Barlett patellofemoral score).

    preoperative and six months postoperatively

  • Functional Outcome

    ROM

    preoperative and six months postoperatively

Study Arms (1)

trochlear thickness change

Radiological Assessment of trochlear thickness of PFJ in primary TKR by preoperative and postoperative CT scan. and observing Effects of Ct Different measures changes in trochlear thickness on short term TKR outcomes

Other: CT trochlear thickness change

Interventions

Preoperative and postoperative CT scan measuring trochlear thickness of PFJ was defined as distance from deepest part of trochlea and line tangential to the anterior aspect of the femoral cortex. It was assessed on the sagittal cuts. CT images will be viewed using Sante DICOM viewer version 5.4.2 and image fusion will be done using Overlay multiple image software. Two observers will measure the angles and the intraobserver and interobserver reliabilities will be assessed for consistency by the intraclass correlation coefficient (ICC) and reliability coefficient using the SPSS software

trochlear thickness change

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with primary knee osteoarthritis

You may qualify if:

  • Advanced knee osteoarthritis in which total knee arthroplasty is indicated

You may not qualify if:

  • Revision total knee arthroplasty
  • Previous osteotomy around the knee
  • Post traumatic knee arthritis
  • Inflammatory knee arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Sahms University

Cairo, Abbasia, 11517, Egypt

Location

Related Publications (3)

  • Ranawat CS, Flynn WF Jr, Saddler S, Hansraj KK, Maynard MJ. Long-term results of the total condylar knee arthroplasty. A 15-year survivorship study. Clin Orthop Relat Res. 1993 Jan;(286):94-102.

  • Healy WL, Wasilewski SA, Takei R, Oberlander M. Patellofemoral complications following total knee arthroplasty. Correlation with implant design and patient risk factors. J Arthroplasty. 1995 Apr;10(2):197-201. doi: 10.1016/s0883-5403(05)80127-5.

  • Dejour H, Walch G, Neyret P, Adeleine P. [Dysplasia of the femoral trochlea]. Rev Chir Orthop Reparatrice Appar Mot. 1990;76(1):45-54. French.

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ibrahim B Anis, MS

    Ain Shams University

    PRINCIPAL INVESTIGATOR
  • Wael S Abd El Mageed, MD

    Ain Shams University

    STUDY DIRECTOR
  • Sherif M El Sayed, MD

    Ain Shams University

    STUDY DIRECTOR
  • Zeiad M Zakaria, MD

    Ain Shams University

    STUDY DIRECTOR
  • Mohmed E Awad, MD

    Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. lecturer.

Study Record Dates

First Submitted

July 14, 2024

First Posted

August 15, 2024

Study Start

September 30, 2022

Primary Completion

May 1, 2024

Study Completion

July 1, 2024

Last Updated

August 15, 2024

Record last verified: 2024-08

Locations