NCT00894361

Brief Summary

This study will be designed to compare prospectively, in a randomized fashion, the clinical, functional, and radiographic results of a nonmodular (all-polyethylene tibi/AP) fixed-bearing posterior cruciate substituting design with a modular posterior cruciate substituting rotating platform (RP) design for total knee arthroplasty. Comparing these two designs will afford the investigators information in the following areas:

  1. 1.Does a RP design offer improvement in range of motion over a AP design?
  2. 2.Does a RP design have improved wear characteristics over a nonmodular AP design?
  3. 3.Is there a clear clinical advantage to the RP design that justifies its increased cost?

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2001

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 7, 2009

Completed
Same day until next milestone

Results Posted

Study results publicly available

May 7, 2009

Completed
Last Updated

September 7, 2020

Status Verified

September 1, 2020

Enrollment Period

5.3 years

First QC Date

March 24, 2009

Results QC Date

March 24, 2009

Last Update Submit

September 3, 2020

Conditions

Osteoarthritis, Knee

Keywords

knee arthritistotal knee arthroplastytotal knee replacementmobile bearing designall-polyethylene tibia

Outcome Measures

Primary Outcomes (1)

  • Knee Postoperative Range of Motion (ROM) at 2 Years

    range of motion of the knee postoperatively at 2 years

    2 years

Secondary Outcomes (1)

  • Survival of the Implants to Subject Death or Implant Removal

    10 or more years

Study Arms (2)

rotating-platform design TKA

ACTIVE COMPARATOR

patients who were randomized to receive the rotating platform mobile-bearing TKA design

Procedure: TKA surgery with the rotating platform mobile-bearing knee design

all-polyethylene tibia design TKA

ACTIVE COMPARATOR

patients who were randomized to receive the all-polyethylene tibial component design

Procedure: TKA surgery with the all-polyethylene tibia knee design

Interventions

TKA surgery with the rotating platform mobile-bearing knee designPROCEDURE

Depuy Sigma RP rotating platform design

rotating-platform design TKA
TKA surgery with the all-polyethylene tibia knee designPROCEDURE

Depuy Sigma fixed-bearing design with all-polyethylene tibia

all-polyethylene tibia design TKA

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • generally accepted clinical and radiographic criteria for primary total knee arthroplasty

You may not qualify if:

  • substantial angular deformity or bony deformity requiring structural grafting or modular augmentation were excluded at the discretion of the principle investigator
  • patients whose mental function precluded them from responding to our standard questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis VAMC

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (1)

  • Gioe TJ, Glynn J, Sembrano J, Suthers K, Santos ER, Singh J. Mobile and fixed-bearing (all-polyethylene tibial component) total knee arthroplasty designs. A prospective randomized trial. J Bone Joint Surg Am. 2009 Sep;91(9):2104-12. doi: 10.2106/JBJS.H.01442.

    PMID: 19723986RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Limitations and Caveats

PI/study coordinator retired due to personal family health matters and study sponsor then withdrew funding. Study terminated and no data was collected or analyzed from any participant.

Results Point of Contact

Title
Terence J. Gioe, M.D.
Organization
PI/study coordinator retired due to personal family health matters and study sponsor then withdrew funding. Study terminated and no data was collected or analyzed from any participant.
tjgioe@gmail.com

Study Officials

  • Terence J Gioe, M.D.

    Minneapolis VAMC, Dept. of Orthopaedic Surgery

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Dept. of Orthopaedic Surgery, Minneapolis VAMC

Study Record Dates

First Submitted

March 24, 2009

First Posted

May 7, 2009

Study Start

October 1, 2001

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

September 7, 2020

Results First Posted

May 7, 2009

Record last verified: 2020-09

Locations

US(1)