Osteoarthritis, KneeNCT03432481

Investigational Testing of Bodycad Unicompartmental Knee Prosthesis (UKS)

A study testing Unicompartmental Knee Arthroplasty Surgery and Bodycad Unicompartmental Knee System (BUKS) in people with Osteoarthritis, Knee, run by Laboratoires Bodycad Inc. at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study is designed to observe clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis of the medial condyle. Read more about this study

Who is it for?: Ages 45 to 70 years
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: Unicompartmental Knee Arthroplasty Surgery and Bodycad Unicompartmental Knee System (BUKS)
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteCanada
Study dates: 24 Jan 2018to 7 Mar 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Medial unicompartmental knee osteoarthritic disease diagnosed on the basis of the American College of Rheumatology criterion with radiographic confirmation (Kellgren- Lawrence grade 3 or higher, on a scale of 0 to 4, with higher numbers indicating more severe signs of osteoarthritis); or isolated medial compartment post-traumatic arthritis supported by long film (x-ray);
Between the ages of at least 45 years and 70 years (inclusive) at the time of enrollment;
Stable health as judged by the Investigator;
Willingness to adhere to the protocol requirements as evidenced by the informed consent form duly read, signed and dated by the subject.

Who cannot join

Presence of active or latent infection in the knee;
Diagnosis of rheumatoid arthritis or avascular necrosis;
Presence of moderate patellofemoral osteoarthritic disease or patellofemoral maltracking;
Anterior or posterior translational, varus or valgus ligamentous knee instability and/or deformity;
Extension deficit > 15˚ of affected knee;
History of ligament surgery on the affected knee, patient that already have a prosthesis on other condyles of the affected knee and/or patient requiring a revision knee replacement surgery;

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History of proximal tibial fracture, non-union, deformity or oblique joint line;
Deficient bone mass that may not provide adequate support and / or fixation;
Skeletal immaturity;
Obesity: BMI above 35
Risk of exposing the prosthesis to overload by the practice of contact or high impact sports such as: baseball, hockey, basketball, football, soccer, karate, skiing etc;
Known sensitivity to CoCrMo, Titanium, and polyethylene components of the UKS Prosthesis used in the manufacturing of the prosthesis;
Pre-existing medical conditions such as history of cancer other than skin cancer, poorly controlled diabetes, systemic infections, immunocompromised, fibromyalgia or other general body pain conditions, which, in the opinion of the Investigator, interfere with the conduct of the study;
Neuromuscular condition that could lead to an unacceptable risk of instability of the prosthesis or other postoperative complications;
Subjects, in the opinion of the Investigator, who are unlikely to comply with the protocol (e.g. active alcoholism, drug dependency or psychotic state, unable or unwilling to adhere to study visit schedule);
Pregnant or nursing female subjects; or female subjects planning on becoming pregnant within the next 60 months from enrollment;
Subjects under guardianship, hospitalized in a public or private institution, for a reason other than research, or subject deprived of freedom;
Participation in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.

Trial locations and contacts

1 site in 1 country.

Canada1 site

CHU de Quebec - Universite Laval
Québec, G1J1Z4

Other trials in Canada

About this study

Official title: Open-Label Investigational Testing of Bodycad Unicompartmental Knee Prosthesis (UKS) in Human Subjects With Medial Unicompartmental Knee Osteoarthritis

This study is designed to observe clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis of the medial condyle.

Read the detailed description

The patient-specific Bodycad Unicompartmental Knee System will be implanted on patients with knee osteoarthritis of the medial condyle. The study's hypothesis is that personalized shape and fit of patient-specific knee replacement prosthesis will provide a greater stability and a more natural knee motion in addition to a faster recovery when compared to traditional knee replacement systems. This study is designed to provide a five-years follow-up clinical data on safety and effectiveness of the device.

Conditions: Osteoarthritis, Knee
Being tested: Unicompartmental Knee Arthroplasty Surgery, Bodycad Unicompartmental Knee System (BUKS)
Keywords: Osteoarthritis, Knee
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Unicompartmental Knee Arthroplasty SurgeryProcedure or surgery
Unicompartmental Knee Arthroplasty Surgery using the Bodycad Unicompartmental Knee System (BUKS)
Bodycad Unicompartmental Knee System (BUKS)Device
Unicompartmental Knee Arthroplasty Surgery using the Bodycad Unicompartmental Knee System (BUKS)

Study groups in NCT03432481
Study group	Role	What they receive
Knee Arthroplasty using BUKS	Experimental	Unicompartmental Knee Arthroplasty Surgery Receives: Procedure: Unicompartmental Knee Arthroplasty Surgery; Device: Bodycad Unicompartmental Knee System (BUKS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in Knee Society Score (KSS) Objective
Assessment of improvement of clinical outcomes following BUKS implantation using the KSS questionnaire, to evaluate the clinical performance of the articulation
Measured: Baseline, post-operative months 3, 6, 12, 24, 36, 48 and 60
Change from baseline in Knee Osteoarthritis Outcome Score (KOOS)
Assessment of improvement of activity levels following BUKS implantation surgery using the KOOS questionnaire
Measured: Baseline, post-operative months 3, 6, 12, 24, 36, 48 and 60

Secondary outcomes (3)

Change from baseline in mechanical axis measurement.
Determine by radiographic analysis Varus or Valgus, expected value are +/- 3 degrees
Measured: Baseline and post operative week 1
Change from baseline of implant position fixation
The anteroposterior and medial lateral slop will be evaluated according to initial planed position. The measured angles will be compared with initial planning. The expected values are +/- 1.5 degree.
Measured: Post operative week 6, months 6, 12, 24, 36, 48 and 60
Change from baseline on bone loss and cementation
Those measurements will be done on x-ray of the patient joint following Knee Society Radiological evaluation form.The tibial component acceptable score for this device will be 2.5 mm. The femoral component acceptable score for this device will be 6 mm.
Measured: Post operative week 6, months 6, 12, 24, 36, 48 and 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jan 20187 Mar 2023

First posted14 Feb 2018
Study start24 Jan 2018
Primary completion20 Aug 2020
Study completion7 Mar 2023

Why it stopped: interruption due to the ongoing corporate restructuring, which has resulted in the cessation of our interest in pursuing any clinical activities related to the product.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Single group
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03432481
Sponsor's protocol ID: PRO-PB001-42
Status last verified: Aug 2023
First submitted: 22 Jan 2018
Last updated: 25 Aug 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-Label Investigational Testing of Bodycad Unicompartmental Knee Prosthesis (UKS) in Human Subjects With Medial Unicompartmental Knee Osteoarthritis
ClinicalTrials.gov ID: NCT03432481
Acronym / sponsor ID: PRO-PB001-42
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis, Knee
Study type: Interventional
Recruitment status: TerminatedReason stopped: interruption due to the ongoing corporate restructuring, which has resulted in the cessation of our interest in pursuing any clinical activities related to the product.
Enrolment: 28 participants (actual)
Lead sponsor: Laboratoires Bodycad Inc.Industry (pharma, biotech, devices)
Study start: 24 Jan 2018 (actual)
Primary completion: 20 Aug 2020 (actual)
Study completion: 7 Mar 2023 (actual)
First posted: 14 Feb 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is designed to observe clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis of the medial condyle.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single group

Arm	Type	Receives
Knee Arthroplasty using BUKS	Experimental	Procedure: Unicompartmental Knee Arthroplasty Surgery, Device: Bodycad Unicompartmental Knee System (BUKS)Unicompartmental Knee Arthroplasty Surgery

Who may qualify

Ages: 45 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Medial unicompartmental knee osteoarthritic disease diagnosed on the basis of the American College of Rheumatology criterion with radiographic confirmation (Kellgren- Lawrence grade 3 or higher, on a scale of 0 to 4, with higher numbers indicating more severe signs of osteoarthritis); or isolated medial compartment post-traumatic arthritis supported by long film (x-ray);
Between the ages of at least 45 years and 70 years (inclusive) at the time of enrollment;
Stable health as judged by the Investigator;
Willingness to adhere to the protocol requirements as evidenced by the informed consent form duly read, signed and dated by the subject.

Key exclusion criteria (18 listed)

Presence of active or latent infection in the knee;
Diagnosis of rheumatoid arthritis or avascular necrosis;
Presence of moderate patellofemoral osteoarthritic disease or patellofemoral maltracking;
Anterior or posterior translational, varus or valgus ligamentous knee instability and/or deformity;
Extension deficit > 15˚ of affected knee;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Unicompartmental Knee Arthroplasty SurgeryUnicompartmental Knee Arthroplasty Surgery using the Bodycad Unicompartmental Knee System (BUKS)	Procedure or surgery	Knee Arthroplasty using BUKS
Bodycad Unicompartmental Knee System (BUKS)Unicompartmental Knee Arthroplasty Surgery using the Bodycad Unicompartmental Knee System (BUKS)	Device	Knee Arthroplasty using BUKS

Primary outcome

Change from baseline in Knee Society Score (KSS) Objective
Time frame: Baseline, post-operative months 3, 6, 12, 24, 36, 48 and 60
Assessment of improvement of clinical outcomes following BUKS implantation using the KSS questionnaire, to evaluate the clinical performance of the articulation
Change from baseline in Knee Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, post-operative months 3, 6, 12, 24, 36, 48 and 60
Assessment of improvement of activity levels following BUKS implantation surgery using the KOOS questionnaire

3 secondary outcomes

Change from baseline in mechanical axis measurement.
Time frame: Baseline and post operative week 1
Change from baseline of implant position fixation
Time frame: Post operative week 6, months 6, 12, 24, 36, 48 and 60
Change from baseline on bone loss and cementation
Time frame: Post operative week 6, months 6, 12, 24, 36, 48 and 60

Results and safety

The study was stopped early (reason given: interruption due to the ongoing corporate restructuring, which has resulted in the cessation of our interest in pursuing any clinical activities related to the product.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
Individual participant dataSharing planned: Undecided

Related trials for Osteoarthritis, Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Etienne Belzile, MD principal investigator

CHU de Quebec - Hopital de l'Enfant-Jésus

Brian Hamlin, MD study chair

Renaissance Orthopedics

Geoffroy Rivet-Sabourin, PhD study director

Laboratoires Bodycad Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Unicompartmental Knee Arthroplasty Surgery and Bodycad Unicompartmental Knee System (BUKS) in people with Osteoarthritis, Knee, run by Laboratoires Bodycad Inc. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Knee Society Score (KSS) Objective (time frame: Baseline, post-operative months 3, 6, 12, 24, 36, 48 and 60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03432481.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.