NCT02429856

Brief Summary

This randomized clinical trial (RCT) examined 10 year outcomes comparing SCORPIO™ Posterior Cruciate Substituting (PCS) versus Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty (TKA) as the primary outcome.

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_4

Timeline
Completed

Started Feb 1999

Longer than P75 for phase_4

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

February 1, 1999

Completed
14.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
4 years until next milestone

Results Posted

Study results publicly available

May 13, 2019

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

14.3 years

First QC Date

April 17, 2015

Results QC Date

December 12, 2016

Last Update Submit

July 23, 2021

Conditions

Arthroplasty, Replacement, KneeKnee Arthroplasty, Total

Outcome Measures

Primary Outcomes (2)

  • Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain

    disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores

    10 years postoperative

  • WOMAC Osteoarthritis Index Function

    disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores

    10 years

Secondary Outcomes (4)

  • RAND -36 Health Survey

    10 years postoperative

  • Revision Rate

    within 10 years of surgery

  • Number of Complications

    within 10 years of surgery

  • Knee Range of Motion

    knee ROM at 2 years postoperative

Study Arms (2)

PCS

ACTIVE COMPARATOR

SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis

Device: SCORPIO™

PCR

ACTIVE COMPARATOR

SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis

Device: SCORPIO™

Interventions

SCORPIO™DEVICE

subjects randomized at surgery to receive 1 of the 2 specified implants

PCRPCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • scheduled for primary TKA
  • non-inflammatory arthritis
  • intact Posterior Cruciate Ligament at the time of surgery

You may not qualify if:

  • required bone grafting of either the femur or tibia
  • varus or valgus deformity of \> 15 degrees
  • previous high tibial osteotomy
  • unable to understand or comply with the study requirements
  • unable to provide signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alberta Health Services - Edmonton zone

Edmonton, Alberta, TG6 2B7, Canada

Location

Related Publications (1)

  • Chaudhary R, Beaupre LA, Johnston DW. Knee range of motion during the first two years after use of posterior cruciate-stabilizing or posterior cruciate-retaining total knee prostheses. A randomized clinical trial. J Bone Joint Surg Am. 2008 Dec;90(12):2579-86. doi: 10.2106/JBJS.G.00995.

    PMID: 19047702RESULT

Results Point of Contact

Title
Director of NACTRC
Organization
UAlberta
ron.welch@ahs.ca
780-407-8007

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2015

First Posted

April 29, 2015

Study Start

February 1, 1999

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

July 27, 2021

Results First Posted

May 13, 2019

Record last verified: 2021-07

Locations

CA(1)