NCT01855906

Brief Summary

The purpose of this study is to examine the impact of two surgical techniques on the outcome of the knee replacement surgery.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

2 years

First QC Date

May 14, 2013

Last Update Submit

March 9, 2016

Conditions

Osteoarthritis

Keywords

Total knee replacementGap balancedMeasured resection

Outcome Measures

Primary Outcomes (1)

  • The primary objective will be to assess coronal balance through a range of motion.

    Assessed through dynamic fluoroscopic analysis.

    One year post-operatively

Secondary Outcomes (1)

  • Patellofemoral tracking

    One year post-operatively

Study Arms (2)

Gap balanced surgical technique

ACTIVE COMPARATOR

Study patients in this arm of the study will have their knee replacement done using the gap balanced technique. Gap balancing adjusts the bony cuts for femoral rotation to balance the soft tissues of the knee in flexion.

Procedure: Gap balanced surgical technique

Measured resection surgical technique

ACTIVE COMPARATOR

Study patients in this arm of the study will have their knee replacement done using the measured resection surgical technique. Pre-determined bony cuts are made and appropriate balance is obtained by judicious soft tissue releases as required.

Procedure: Measured resection

Interventions

Gap balanced surgical techniquePROCEDURE

Gap balanced surgical technique

Gap balanced surgical technique
Measured resectionPROCEDURE

Measured resection surgical technique

Measured resection surgical technique

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Surgeon and patient have determined that patient requires a primary total knee arthroplasty and agrees to participate and signs the informed consent for study.

You may not qualify if:

  • History of alcoholism
  • Unable to speak English
  • Inflammatory Arthritis
  • Pregnant women or any woman with plans to begin a family.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Brent Lanting, MD.

    London Health Sciences Centre - University Hospital

    PRINCIPAL INVESTIGATOR
0

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
Orthopaedic Surgeon

Study Record Dates

First Submitted

May 14, 2013

First Posted

May 17, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2016

Last Updated

March 10, 2016

Record last verified: 2016-03

Locations

CA(1)