Joint DiseaseGOLDNCT02589197

Gait and Functional Outcomes Study Following Total Knee Arthroplasty With Medial-pivot or Posterior-stabilized Implants

An observational study of Joint Disease, run by MicroPort Orthopedics Inc. at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

MicroPort Orthopedics (MPO) is conducting this study to build upon the results of a previous study which showed the Medial Pivot (MP) system required lower quadriceps activation than subjects implanted with a Posterior stabilized (PS) system preforming the same activities of daily living. Read more about this study

Who is it for?: Ages 45 to 76 yearsHealthy volunteers can take part
Conditions the study is for: Joint Disease
What is being tested?: Group 1 (Medial-Pivot) and Group 2 (Posterior-Stabilized)
Type of treatment: Medical device
How many people: 50 participants
Where: 2 sitesCanada
Study dates: 13 Jul 2016to 30 Sep 2022
Phase: Observational
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 76 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Study population will be selected from the orthopedic clinic at The Ottawa hospital for implanted patients. Non-implanted subjects will be selected from the community.

Who may be able to join

To be included in Groups 1 and 2, subjects must meet all of the following criteria:
Subject is a candidate for unilateral primary TKA for degenerative or traumatic osteoarthritis Subject is a candidate to be implanted with the specified combination of components for either Group 1 or 2 Subjects are at least 45 years old and less than 76 years of age at time of enrollment Subject is willing and able to complete required study visits and assessments Subject plans to be available through the 1 year postoperative follow-up visit Subject is willing to sign the approved Informed Consent document
To be included in Group 3, subjects must meet all of the following criteria:
Subjects are at least 45 years old and less than 76 years of age at time of enrollment Subject is willing and able to complete required study visit and assessments Subject is willing to sign the approved Informed Consent document

Who cannot join

Subjects will be excluded if they meet any of the following criteria:
Subject has both a body mass index (BMI) and waist circumference measurements greater than 35.0 kg/m2 and 102.0 cm respectively for men and 35.0 kg/m2 and 88.0 cm respectively for women at screening.
Groups 1 \& 2 Only: Subject has degenerative conditions (other than osteoarthritis in the enrolled TKA) impacting joints of the lower extremities, previous joint replacement of the enrolled knee or other lower limb joint replacement, or any other past or present condition, which in the opinion of the Investigator may impact gait. Group 3 Only: Subject has degenerative condition impacting joints of the lower extremities, any previous joint replacement in the knees, or any other past or present condition, which in the opinion of the Investigator may impact gait.
Groups 1 and 2 Only: Subjects with a Kellgren-Lawrence Grading Scale of ≥2 on the contralateral knee if having severe pain or abnormal gait patterns.
Subject is currently enrolled in another clinical investigation related to lower limbs which could affect the endpoints of this protocol.
Subject is unwilling or unable to sign the Informed Consent document Subject has documented substance abuse issues Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study Subject is currently incarcerated or has impending incarceration

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
University of Ottawa
Ottawa, Ontario

Other trials in Canada

About this study

Official title: Muscle Activation and Biomechanical Function of the Lower-limb Joints Following Total Knee Arthroplasty With Medial-pivot or Posterior-stabilized Implants: an Electromyography Study

Read the detailed description

Conditions: Joint Disease
Being tested: Group 1 (Medial-Pivot), Group 2 (Posterior-Stabilized)
Keywords: osteoarthritis, correction of functional deformity, procedures, traumatic osteoarthritis, degenerative osteoarthritis, total knee arthroplasty, Healthy Volunteers, electromyography, Musculoskeletal Diseases
Medical subject headings: Joint Diseases, Osteoarthritis, Musculoskeletal Diseases

What participants receive

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

Group 1 (Medial-Pivot)Device
Also called EVOLUTION® CS TKA System, Total Knee Arthroplasty Sytem, EVOLUTION®
EVOLUTION® Total Knee Arthroplasty Medial Pivot system with CS inserts
Group 2 (Posterior-Stabilized)Device
Also called Zimmer® NexGen® PS TKA System, Total Knee Arthroplasty Sytem, NexGen®
Zimmer® NexGen® Total Knee Arthroplasty system with PS inserts

Study groups in NCT02589197
Study group	Role	What they receive
Group 1 (Medial-Pivot)		Group 1 will be implanted with the EVOLUTION® MP System with Cruciate Sacrificing (CS) tibial inserts. Receives: Device: Group 1 (Medial-Pivot)
Group 2 (Posterior-Stabilized)		Group 2 will be implanted with the Zimmer® NexGen® PS TKA system. Receives: Device: Group 2 (Posterior-Stabilized)
Group 3 (Control Group)		Non-implanted control subjects

What is being measured

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

Lower Limb Muscle Activation Comparison as Assessed by Maximum Voluntary Isometric Contraction Muscle Strength and Dynamic Muscle Activation Measurements in Total Knee Arthroplasty Subjects Implanted with Medial-pivot or Posterior-stabilized Implants
Measured by Dynamic Muscle Activation Measurements and Maximum Voluntary Isometric Contraction Muscle Strength and Activation
Measured: Presurgery and 12 Months Post Surgery

Secondary outcomes (4)

Compare lower limb muscle activation between the control group (Group 3) and Groups 1 and 2, as assessed by maximum voluntary isometric contraction muscled strength and dynamic muscle activation measurements
Measured by Dynamic Muscle Activation Measurements and Maximum Voluntary Isometric Contraction Muscle Strength and Activation
Measured: Presurgery and 12 Months Post Surgery for implanted subjects
Compare functional outcomes for the Groups 1 and 2 as assessed by the Timed Up & Go (TUG) test
Measured by Timed Up \& Go (TUG) test
Measured: Presurgery and 12 Months Post Surgery for implanted subjects
Compare functional outcomes for the Groups 1 and 2 as assessed by the KOOS Scores
Measured by KOOS Scores
Measured: Presurgery and 12 Months Post Surgery for implanted subjects
Compare subject satisfaction using a custom five question patient satisfaction questionnaire for Groups 1 and 2
Measured by Patient Satisfaction Survey
Measured: 12 Months Post Surgery

Timeline

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

13 Jul 201630 Sep 2022

First posted28 Oct 2015 (estimated)
Study start13 Jul 2016
Primary completionSep 2022
Study completion30 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Joint DiseaseStudies of the same condition, open and under way.
More trials run by MicroPort Orthopedics Inc.The sponsor's other registered studies.
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: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02589197
Sponsor's protocol ID: 15-LJK-001
Acronym: GOLD
Status last verified: Nov 2022
First submitted: 19 Oct 2015
Last updated: 25 Nov 2022
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Kowalski E, Catelli DS, Pelegrinelli ARM, Dervin G, Lamontagne M. EFORT Michael Freeman Award 2020: Knee biomechanics before and after total knee arthroplasty with either a medial pivot or posterior stabilized implants. Clin Biomech (Bristol). 2025 Jul;127:106604. doi: 10.1016/j.clinbiomech.2025.106604. Epub 2025 Jun 26.
PubMed 40602029
Kowalski E, Pelegrinelli ARM, Ryan N, Dervin G, Lamontagne M. Muscle Activity and Biomechanics While Descending a Staircase After Total Knee Arthroplasty: A Study Comparing Different Posterior Stabilized and Medial Ball-and-Socket Designs. J Arthroplasty. 2024 Dec;39(12):3076-3083.e2. doi: 10.1016/j.arth.2024.06.022. Epub 2024 Jun 18.
PubMed 38901712

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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An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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All Joint Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Muscle Activation and Biomechanical Function of the Lower-limb Joints Following Total Knee Arthroplasty With Medial-pivot or Posterior-stabilized Implants: an Electromyography Study
ClinicalTrials.gov ID: NCT02589197
Acronym / sponsor ID: GOLD / 15-LJK-001
Conditions: Joint Disease
Keywords: osteoarthritis, correction of functional deformity, procedures, traumatic osteoarthritis, degenerative osteoarthritis, total knee arthroplasty, Healthy Volunteers, electromyography
Study type: Observational
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
Collaborators: University of Ottawa, The Ottawa Hospital
Study start: 13 Jul 2016 (actual)
Primary completion: Sep 2022 (actual)
Study completion: 30 Sep 2022 (actual)
First posted: 28 Oct 2015 (estimated)
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.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Group 1 (Medial-Pivot)	–	Device: Group 1 (Medial-Pivot)Group 1 will be implanted with the EVOLUTION® MP System with Cruciate Sacrificing (CS) tibial inserts.
Group 2 (Posterior-Stabilized)	–	Device: Group 2 (Posterior-Stabilized)Group 2 will be implanted with the Zimmer® NexGen® PS TKA system.
Group 3 (Control Group)	–	–Non-implanted control subjects

Who may qualify

Ages: 45 to 76 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Study population will be selected from the orthopedic clinic at The Ottawa hospital for implanted patients. Non-implanted subjects will be selected from the community.

Key inclusion criteria (4 listed)

Subject is a candidate for unilateral primary TKA for degenerative or traumatic osteoarthritis Subject is a candidate to be implanted with the specified combination of components for either Group 1 or 2 Subjects are at least 45 years old and less than 76 years of age at time of enrollment Subject is willing and able to complete required study visits and assessments Subject plans to be available through the 1 year postoperative follow-up visit Subject is willing to sign the approved Informed Consent document
Subjects are at least 45 years old and less than 76 years of age at time of enrollment Subject is willing and able to complete required study visit and assessments Subject is willing to sign the approved Informed Consent document

Key exclusion criteria (6 listed)

Subject has both a body mass index (BMI) and waist circumference measurements greater than 35.0 kg/m2 and 102.0 cm respectively for men and 35.0 kg/m2 and 88.0 cm respectively for women at screening.
Groups 1 \& 2 Only: Subject has degenerative conditions (other than osteoarthritis in the enrolled TKA) impacting joints of the lower extremities, previous joint replacement of the enrolled knee or other lower limb joint replacement, or any other past or present condition, which in the opinion of the Investigator may impact gait. Group 3 Only: Subject has degenerative condition impacting joints of the lower extremities, any previous joint replacement in the knees, or any other past or present condition, which in the opinion of the Investigator may impact gait.
Groups 1 and 2 Only: Subjects with a Kellgren-Lawrence Grading Scale of ≥2 on the contralateral knee if having severe pain or abnormal gait patterns.
Subject is currently enrolled in another clinical investigation related to lower limbs which could affect the endpoints of this protocol.
Subject is unwilling or unable to sign the Informed Consent document Subject has documented substance abuse issues Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study Subject is currently incarcerated or has impending incarceration

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
Group 1 (Medial-Pivot)Also: EVOLUTION® CS TKA System, Total Knee Arthroplasty Sytem, EVOLUTION®EVOLUTION® Total Knee Arthroplasty Medial Pivot system with CS inserts	Device	Group 1 (Medial-Pivot)
Group 2 (Posterior-Stabilized)Also: Zimmer® NexGen® PS TKA System, Total Knee Arthroplasty Sytem, NexGen®Zimmer® NexGen® Total Knee Arthroplasty system with PS inserts	Device	Group 2 (Posterior-Stabilized)

Primary outcome

Lower Limb Muscle Activation Comparison as Assessed by Maximum Voluntary Isometric Contraction Muscle Strength and Dynamic Muscle Activation Measurements in Total Knee Arthroplasty Subjects Implanted with Medial-pivot or Posterior-stabilized Implants
Time frame: Presurgery and 12 Months Post Surgery
Measured by Dynamic Muscle Activation Measurements and Maximum Voluntary Isometric Contraction Muscle Strength and Activation

4 secondary outcomes

Compare lower limb muscle activation between the control group (Group 3) and Groups 1 and 2, as assessed by maximum voluntary isometric contraction muscled strength and dynamic muscle activation measurements
Time frame: Presurgery and 12 Months Post Surgery for implanted subjects
Compare functional outcomes for the Groups 1 and 2 as assessed by the Timed Up & Go (TUG) test
Time frame: Presurgery and 12 Months Post Surgery for implanted subjects
Compare functional outcomes for the Groups 1 and 2 as assessed by the KOOS Scores
Time frame: Presurgery and 12 Months Post Surgery for implanted subjects
Compare subject satisfaction using a custom five question patient satisfaction questionnaire for Groups 1 and 2
Time frame: 12 Months Post Surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
Derived from this study: PubMed 40602029Kowalski E, Catelli DS, Pelegrinelli ARM, Dervin G, Lamontagne M. EFORT Michael Freeman Award 2020: Knee biomechanics before and after total knee arthroplasty with either a medial pivot or posterior stabilized implants. Clin Biomech (Bristol). 2025 Jul;127:106604. doi: 10.1016/j.clinbiomech.2025.106604. Epub 2025 Jun 26.
Derived from this study: PubMed 38901712Kowalski E, Pelegrinelli ARM, Ryan N, Dervin G, Lamontagne M. Muscle Activity and Biomechanics While Descending a Staircase After Total Knee Arthroplasty: A Study Comparing Different Posterior Stabilized and Medial Ball-and-Socket Designs. J Arthroplasty. 2024 Dec;39(12):3076-3083.e2. doi: 10.1016/j.arth.2024.06.022. Epub 2024 Jun 18.
Individual participant dataSharing planned: No

Related trials for Joint Disease

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Recruiting
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Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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Not yet recruiting
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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.

Geoffrey Dervin, MD principal investigator

Ottawa Hospital

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

Questions about this trial

What is this clinical trial studying?

An observational study of Joint Disease, run by MicroPort Orthopedics Inc. at 2 sites 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 6 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: finished, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Lower Limb Muscle Activation Comparison as Assessed by Maximum Voluntary Isometric Contraction Muscle Strength and Dynamic Muscle Activation Measurements in Total Knee Arthroplasty Subjects Implanted with Medial-pivot or Posterior-stabilized Implants (time frame: Presurgery and 12 Months Post Surgery). 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 NCT02589197, which also lists 2 linked publications.

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 Nov 2022.