NCT02002624

Brief Summary

The aim of this prospective multicenter randomized clinical trial (RCT) is to compare the clinical and radiologic results of primary total knee arthroplasty (TKA) using patient-specific versus conventional instrumentation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration 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

September 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
Last Updated

December 6, 2013

Status Verified

December 1, 2013

Enrollment Period

1.8 years

First QC Date

December 1, 2013

Last Update Submit

December 5, 2013

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

  • Mechanical axis

    Lower limb mechanical axis was measured on a bipodal standing leg-length anteroposterior radiograph with the patella oriented straight made three months postoperatively, using Roman software version 1.70 (Oswestry, United Kingdom). Postoperative lower limb mechanical axis was calculated from the HKA (hip-knee-ankle) angle between the femoral and tibial mechanical axes, respectively. An HKA angle greater than 180° was indicative of valgus, whereas values lower than 180° indicated varus.

    3 months

Secondary Outcomes (1)

  • Components position

    3 months

Other Outcomes (1)

  • Blood loss

    5 days

Study Arms (2)

Conventional

ACTIVE COMPARATOR

Conventional instrumentation

Device: Conventional instrumentation

PSI

EXPERIMENTAL

Patient specific instrumentation

Device: PSI

Interventions

PSIDEVICE
Also known as: Patient specific instrumentation
PSI
Conventional instrumentationDEVICE
Conventional

Eligibility Criteria

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

You may qualify if:

  • patients with primary or secondary osteoarthritis of the knee requiring total knee arthroplasty
  • aged between 18 and 85 years
  • able to understand information
  • affiliated to social security.

You may not qualify if:

  • active or suspected sepsis
  • tumor around the knee
  • previous partial or total knee replacement
  • presence of hardware that could artifact MRI
  • contraindication to MRI
  • extra-articular deformation requiring osteotomy around the knee in conjunction with TKA
  • social situation that could impair follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Stephane Boisgard, MD, PhD

    University Hospital, Clermont-Ferrand

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
AMBIG
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 1, 2013

First Posted

December 6, 2013

Study Start

September 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

December 6, 2013

Record last verified: 2013-12