Unicompartmental Knee Arthroplasty Surgery for Osteoarthritis

CHU de Quebec - Universite Laval, Quebec, Canada
OsteoarthritisUnicompartmental Knee Arthroplasty Surgery - Procedure
Eligibility
45 - 70
All Sexes
What conditions do you have?
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Study Summary

This trial will look at how well a patient-specific knee replacement works for people with osteoarthritis in the medial condyle.

Eligible Conditions
  • Osteoarthritis of the Knee

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Post operative week 6, months 6, 12, 24, 36, 48 and 60

Week 1
Change from baseline in mechanical axis measurement.
Month 3
Change from baseline in Knee Osteoarthritis Outcome Score (KOOS)
Change from baseline in Knee Society Score (KSS) Objective
Month 6
Change from baseline of implant position fixation
Change from baseline on bone loss and cementation

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Knee Arthroplasty using BUKS
1 of 1

Experimental Treatment

35 Total Participants · 1 Treatment Group

Primary Treatment: Unicompartmental Knee Arthroplasty Surgery · No Placebo Group · N/A

Knee Arthroplasty using BUKSExperimental Group · 2 Interventions: Unicompartmental Knee Arthroplasty Surgery, Bodycad Unicompartmental Knee System (BUKS) · Intervention Types: Procedure, Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: post operative week 6, months 6, 12, 24, 36, 48 and 60

Who is running the clinical trial?

Laboratoires Bodycad Inc.Lead Sponsor
Etienne Belzile, MDPrincipal InvestigatorCHU de Quebec - Hopital de l'Enfant-Jésus
Brian Hamlin, MDStudy ChairRenaissance Orthopedics
Geoffroy Rivet-Sabourin, PhDStudy DirectorLaboratoires Bodycad Inc.

Eligibility Criteria

Age 45 - 70 · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

What is the enrollment quota for this research project?

"Affirmative. Clinicaltrials.gov attests that, since its inception on January 24th 2018 and most recent update on August 14th, this research initiative is actively searching for volunteers to enrol in the trial at a single site and total of 35 participants is sought after." - Anonymous Online Contributor

Unverified Answer

Is there still an opportunity to become involved in this research project?

"This trial, which was first posted on January 24th 2018 as per clinicaltrials.gov records, is presently recruiting patients for participation. The data about the study was last updated on August 14th 2018." - Anonymous Online Contributor

Unverified Answer

Is it possible to participate in this trial?

"Meeting criteria for this clinical trial requires that the patient has a diagnosis of osteoarthritis in their knee and is between 45-70 years old. 35 individuals are eligible to enroll in the study." - Anonymous Online Contributor

Unverified Answer

Is the population base of this medical trial limited to those under 55 years old?

"This clinical trial requires participants aged 45 to 70. Conversely, there are 38 trials catered towards minors and 657 for senior citizens." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.