NCT00405470

Brief Summary

The purpose of this study is to determine whether this particular knee replacement is better than those already on the market. By participation, it will further refine the design of future total knee replacements and perhaps increase longevity.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2001

Longer than P75 for not_applicable

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

July 1, 2001

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2006

Completed
Last Updated

August 12, 2010

Status Verified

August 1, 2010

Enrollment Period

3.9 years

First QC Date

November 28, 2006

Last Update Submit

August 11, 2010

Conditions

Osteoarthritis, Knee

Keywords

arthroplastyRSAmicromotionosteoarthritis

Outcome Measures

Primary Outcomes (1)

  • tibial implant micromotion relative to tibia at 2 years

    2 years postoperative

Study Arms (2)

Medial Pivot

ACTIVE COMPARATOR
Device: Advance Medial Pivot Knee Arthroplasty

Posterior Stabilized

ACTIVE COMPARATOR
Device: Advance Medial Pivot Knee Arthroplasty

Interventions

Advance Medial Pivot Knee ArthroplastyDEVICE

medial pivot total knee arthroplasty tibial component vs standard posterior stabilized tibial component with post. Medial pivot provides a constrained medial condyle through shape of polyethylene and reduces amount of bone removal on femoral side that would otherwise be removed to accommodate PS post

Medial PivotPosterior Stabilized

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary osteoarthritis of the knee
  • Mono-articular disease (Charnley Modified Type A)

You may not qualify if:

  • Significant co-morbidity affecting ability to ambulate
  • Flexion contracture greater than 15°
  • Tibial subluxation greater than 10 mm on standing AP radiograph
  • Greater than 10° of varus or 15° of valgus
  • Extension lag greater than 10°
  • Lateral or medial collateral ligament instability (\> 10° varus/valgus)
  • Previous osteotomy about the knee
  • Previous arthroplasty of the knee
  • Previous patellectomy
  • Leg length discrepancy greater than 10 mm
  • Morbid obesity (obesity that results in significant systemic problems)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Michael Gross, MD FRCSC PhD

    Dalhousie University & Capital District Health Authority

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 28, 2006

First Posted

November 30, 2006

Study Start

July 1, 2001

Primary Completion

June 1, 2005

Study Completion

June 1, 2006

Last Updated

August 12, 2010

Record last verified: 2010-08