NCT01312532

Brief Summary

The purpose of this study is to determine which prosthesis is better in total knee arthroplasty

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_2

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

June 1, 2004

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2011

Completed
Last Updated

March 10, 2011

Status Verified

June 1, 2004

Enrollment Period

6.4 years

First QC Date

March 9, 2011

Last Update Submit

March 9, 2011

Conditions

Osteoarthritis

Keywords

Total knee arthroplastyFixed-bearingMobile-bearing

Outcome Measures

Primary Outcomes (1)

  • Knee Society Scoring

    was used for evaluating the function of the knee and high scores indicated better knee function

    five years after surgery

Secondary Outcomes (1)

  • Pain

    five years after surgery

Study Arms (2)

fixed-bearing

OTHER

fixed-bearing device is a kind of prosthesis

Device: fixed-bearing (P.F.C.® Sigma)

mobile-bearing

OTHER

mobile-bearing device is a kind of prosthesis

Device: mobile-bearing (P.F.C.® Sigma)

Interventions

fixed-bearing (P.F.C.® Sigma)DEVICE

P.F.C.® Sigma, DePuy, Johnson \& Johnson, Leeds, UK

fixed-bearing
mobile-bearing (P.F.C.® Sigma)DEVICE

P.F.C.® Sigma, DePuy, Johnson \& Johnson, Leeds, UK

mobile-bearing

Eligibility Criteria

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

You may qualify if:

  • Patients with expected primary total knee arthroplasty

You may not qualify if:

  • Mediolateral instability
  • Infective arthritis
  • Severe deformity
  • Revision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-zahra university hospital

Isfahan, Isfahan, Iran

Location

Related Links

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • mohammad dehghani, A.Professor

    Isfahan University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 9, 2011

First Posted

March 10, 2011

Study Start

June 1, 2004

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

March 10, 2011

Record last verified: 2004-06

Locations

IR(1)