NCT01998321

Brief Summary

the Purpose of this study was to evaluate the short term outcome of patient specific instrument (PSI) in cases of bilateral simultaneous total knee arthroplasty (TKA) for knee osteoarthritis with sever varus

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable knee-osteoarthritis

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

December 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
Last Updated

November 28, 2013

Status Verified

November 1, 2013

Enrollment Period

9 months

First QC Date

November 16, 2013

Last Update Submit

November 23, 2013

Conditions

Knee Osteoarthritis

Keywords

PSI: Patient Specific InstrumentTKA: Total Knee ArthroplastyArticular DeformityVarus

Outcome Measures

Primary Outcomes (1)

  • functional score

    up to 52 weeks

Secondary Outcomes (4)

  • Blood transfusion rate

    up to 52 weeks

  • complication rate

    up to 52 weeks

  • hospital stay

    up to 52 weeks

  • Operative time

    during surgery

Study Arms (2)

TKA using PSI

EXPERIMENTAL

Total Knee Arthroplasty using Patient Specific Instrument

Other: Patient specific instrument

2 TKA using conditional technique.

EXPERIMENTAL

Total Knee Arthroplasty using conditional technique.

Other: conventional technique for TKA

Interventions

Patient specific instrumentOTHER

A special software with the ability to perform 3D planning including sizing, alignment, bone cutting, positioning of implants, simulation \& PSI designing and PSI production

Also known as: PSI
TKA using PSI
conventional technique for TKAOTHER
2 TKA using conditional technique.

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Deformity ranging from 5 to 30 varus,
  • valgus,
  • fixed flexion deformity from 5 to 50
  • wellness to participate in the study

You may not qualify if:

  • absence of deformities varus, valgus, or flexion deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 University

October Six City, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Mahmoud A Hafez, Professor

    October 6 University

    PRINCIPAL INVESTIGATOR

  • Mohamed El Sayed, Dr

    Bone and Joint Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mahmoud A Hafez

Study Record Dates

First Submitted

November 16, 2013

First Posted

November 28, 2013

Study Start

December 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

November 28, 2013

Record last verified: 2013-11

Locations

EG(1)