Trials Sponsors Conditions Drugs Pricing

Conditions

Arthroplasty, Replacement, Knee Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

Prosthesis Survivorship Free of Revision
The survival of prostheses free of revision 10 years post operation.
From operation to 10 years post-operative

Secondary Outcomes (7)

Prosthesis Survivorship Free of Reoperation
From operation to 10 years post-operative
Prosthesis Survivorship Free of Complications
From operation to 10 years post-operative
Knee Society Score (KSS)
Pre-operative (baseline) and 10-years post-operative
Knee Society Score (KSS): Function
Pre-operative (baseline) and 10-years post-operative
12-Item Short Form Health Survey (SF-12): Mental Health Score
Pre-operative (baseline) and 10-years post-operative
+2 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

Stryker Orthopaedics N2Vac Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty.

Device: N2Vac Polyethylene

Treatment

EXPERIMENTAL

Stryker Orthopaedics X3 Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty.

Device: X3 Polyethylene

Interventions

X3 PolyethyleneDevice

Highly cross-linked polyethylene (HXLPE).

Also known as: X3

Treatment

N2Vac PolyethyleneDevice

Ultra-high-molecular-weight polyethylene (UHMWPE).

Also known as: N2Vac

Eligibility Criteria

Age21 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects willing to sign the informed consent.
Subjects able to comply with follow-up requirements including post-operative weight bearing restrictions and self-evaluations.

Sponsors & Collaborators

Mayo Clinic
Otherlead
Stryker Orthopaedics
Industrycollaborator

Study Sites (3)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Mayo Clinic

Jacksonville, Florida, 32224, United States

Mayo Clinic

Rochester, Minnesota, 55905, United States

Limitations and Caveats

Wear related failures require significant lengths of time in which to present, longer-term data are necessary to definitively uncover differential wear and osteolysis risk between HXLPE and UHMWPE. The present investigation strictly utilized cemented femoral and tibial component fixation and posterior stabilized bearing designs. Additionally, 14% of patients were lost to follow-up by 10 years with the potential for bias therein; however, there was no differential attrition between groups.

Results Point of Contact

Title: Emilee Andersen, M.A., Clinical Research Coordinator
Organization: Mayo Clinic, Rochester, MN

Study Officials

Matthew Abdel, MD
Mayo Clinic
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

518 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

June 26, 2007

First Posted

June 28, 2007

Study Start

February 2007

Date type not reported

This date has not been verified as actual or estimated.

X-3 Polyethylene Survival Outcomes Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Control

Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Control

Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations