NCT03511144

Brief Summary

A comparison of two Unity Knee™ tissue-balancing techniques by analysing the results from X-rays and patient questionnaires.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

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withdrawn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

April 11, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

November 21, 2018

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

April 11, 2018

Last Update Submit

November 20, 2018

Conditions

Osteoarthritis, KneeRheumatoid ArthritisPost-Traumatic Osteoarthritis of KneeVarus Deformity, Not Elsewhere Classified, KneeValgus Deformity, Not Elsewhere Classified, KneeFlexion Deformity, KneeFracture of Distal End of FemurFracture of Upper End of Tibia

Outcome Measures

Primary Outcomes (1)

  • Posterior condylar offset (PCO)

    Any difference in PCO from preoperative to 6 weeks post-surgery

    6 weeks post-op

Secondary Outcomes (11)

  • Joint line in extension

    6 weeks post-op

  • Joint line in flexion

    6 weeks post-op

  • Femoral flexion angle

    6 weeks post-op

  • Distal femoral component angle

    6 weeks post-op

  • Tibial component angle

    6 weeks post-op

  • +6 more secondary outcomes

Study Arms (2)

Measured resection

ACTIVE COMPARATOR

Total knee replacement using the Unity Knee™ implanted with the measured resection surgical technique

Device: Unity Knee™ TKR using measured resection

Ligament balancing

ACTIVE COMPARATOR

Total knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique

Device: Unity Knee™ TKR using ligament balancing

Interventions

Unity Knee™ TKR using measured resectionDEVICE

Total knee replacement using the Unity Knee™ implanted with the measured resection surgical technique

Measured resection
Unity Knee™ TKR using ligament balancingDEVICE

Total knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique

Ligament balancing

Eligibility Criteria

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

You may qualify if:

  • Subjects suitable for the Unity Knee™ Total Knee System according to the product "Instructions for use"
  • Over 18 years old
  • Male and female subjects who are skeletally mature
  • Subjects who have a smartphone (iOS or Android) with internet connection via mobile Internet data or Wi-Fi connection
  • Subjects able to understand what is expected of them and be able to comply with the study protocol requirements

You may not qualify if:

  • Any subject listed for a revision total knee replacement or conversion of a unicondylar replacement to a total knee replacement on the operative knee
  • Any subject with fixed flexion contracture greater than 20 degrees
  • Any subject with varus/valgus deformity greater than 15 degrees
  • Any subject with confirmed osteoarthritis or other pathologies affecting the contralateral knee that is anticipated to require surgery within 12 months
  • Any subjects with contralateral knee replacement that is anticipated to require revision surgery within 12 months
  • Any subject whose prospects for a recovery to independent mobility would be compromised by known co-existent, medical problems
  • Any subject with a known sensitivity to device material
  • Any subject who is pregnant
  • Any subject currently a prisoner
  • Any subject known to be a drug or alcohol abuser, or have a psychological disorder that could affect follow-up care or treatment outcomes
  • Any subject currently involved in any personal injury litigation, medical-legal or worker's compensations claims
  • Any subject unable to read and understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, KneeArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2018

First Posted

April 27, 2018

Study Start

July 1, 2018

Primary Completion

September 1, 2019

Study Completion

July 1, 2020

Last Updated

November 21, 2018

Record last verified: 2018-11