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

Joint Disease Clinical Trial

— GOLD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02589197
• Other study ID #: 15-LJK-001
• Status: Completed
• Start date: July 13, 2016
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: MicroPort Orthopedics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Description:

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. The propose of the current study is to determine the impact of Total Knee Arthroplasty (TKA) design on muscle activation following TKA surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 30, 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 76 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Joint Disease
• Joint Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	University of Ottawa	Ottawa	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
MicroPort Orthopedics Inc.	The Ottawa Hospital, University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Presurgery and 12 Months Post Surgery
Secondary	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	Presurgery and 12 Months Post Surgery for implanted subjects
Secondary	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	Presurgery and 12 Months Post Surgery for implanted subjects
Secondary	Compare functional outcomes for the Groups 1 and 2 as assessed by the KOOS Scores	Measured by KOOS Scores	Presurgery and 12 Months Post Surgery for implanted subjects
Secondary	Compare subject satisfaction using a custom five question patient satisfaction questionnaire for Groups 1 and 2	Measured by Patient Satisfaction Survey	12 Months Post Surgery