NCT02145455

Brief Summary

This study will compare two different surgical methods used in total knee replacement with the Unity Total Knee Replacement System. The study will evaluate these two methods based on patients' ability to perform various tasks prior to surgery and at 4 time points during the first 12 months after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

May 20, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
1 year until next milestone

Study Start

First participant enrolled

June 6, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

4.9 years

First QC Date

May 20, 2014

Last Update Submit

July 13, 2020

Conditions

Arthritis of the Knee

Keywords

Arthroplasty, Replacement, Knee/methodsKnee Joint/physiopathologyKnee Joint/radiographyKnee Joint/surgeryKnee ProsthesisOutcome Assessment (Health Care)FemaleMaleAdult

Outcome Measures

Primary Outcomes (1)

  • Power of knee extension

    Power of knee extension via peak torque of quads measured on a digital myometer.

    12 months post-operative

Secondary Outcomes (14)

  • Timed up and go test

    12 months post-operative

  • Single leg stance (SLS) test

    12 months post-operative

  • 6 minute walk test

    12 months post-operative

  • Timed stairs test

    12 months post-operative

  • Wii Fit balance test

    12 months post-operative

  • +9 more secondary outcomes

Study Arms (2)

Mechanical alignment

ACTIVE COMPARATOR

Patients in this arm will have the Unity Total Knee Replacement System implanted using a surgical technique that utilizes mechanical alignment via measured resection to establish knee alignment.

Device: Unity Total Knee Replacement System

Anatomic alignment

ACTIVE COMPARATOR

Patients in this arm will have the Unity Total Knee Replacement System implanted using a surgical technique that utilizes anatomic alignment via ligament balancing with the tibial cut perpendicular to the tibial anatomic axis.

Device: Unity Total Knee Replacement System

Interventions

Unity Total Knee Replacement SystemDEVICE
Also known as: Unity Total Knee Replacement System (Cruciate Retaining), Unity Total Knee Replacement System (Posterior Stabilised)
Mechanical alignment

Eligibility Criteria

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

You may qualify if:

  • The patient must be listed for a primary total knee replacement using the Corin Unity Total Knee Replacement System, according to the product 'Instructions For Use'
  • The patient must give signed informed consent to participate in the study
  • The patient must be able to understand all that is expected of them and be able to comply with the study protocol
  • Male and female patients who are skeletally mature

You may not qualify if:

  • Any patient with a total knee replacement not implanted with a Corin Unity Total Knee Replacement
  • Any patient with a revision total knee replacement or conversion of a Unicondylar replacement to a total knee replacement on the operative knee
  • Any patient with fixed flexion contracture greater than 20 degrees
  • Any patient with varus/valgus deformity greater than 15 degrees
  • Any patient who cannot or will not provide signed informed consent for participation in the study
  • Any patient whose prospects for a recovery to independent mobility would be compromised by known co-existent, medical problems
  • Any patient with a known sensitivity to device material
  • Any patient who is pregnant
  • Any patient currently a prisoner
  • Any patient known to be a drug or alcohol abuser, or have a psychological disorder that could affect follow-up care or treatment outcomes
  • Any patient currently involved in any personal injury litigation, medical-legal or worker's compensations claims
  • Any patient unable to read and understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exeter Knee Reconstruction Unit at the Princess Elizabeth Orthopaedic Centre

Exeter, Devon, EX2 5DW, United Kingdom

Location

Study Officials

  • Andrew Toms, MD

    Princess Elizabeth Orthopaedic Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 23, 2014

Study Start

June 6, 2015

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

GB(1)