Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant

NCT01717001 | Completed Results

• 1 other identifier: Komistek 1
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Previously, most experimental studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested the knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers that permit error due to undesired motions between markers and the underlying bone. More recently, fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA. ConforMIS has attempted to follow a clearly different path than the major orthopaedic companies. They have chosen to offer patients a personalized knee implant based off of each patient's femoral and tibial bone geometry. The hypothesis is that these subjects will experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding during weight-bearing knee flexion. Therefore, the objective for this study is to analyze the in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25 patients implanted with a traditional TKA design to determine if there are any kinematic differences between these TKA designs.

Conditions

Osteoarthritis

Keywords

kinematics; knee joint

Outcome Measures

Primary Outcomes (1)

• Post-operative Range of Motion

  Comparison of amount of flexion achieved by the knee between the two arms

  at least 6 months post-surgery

Study Arms (2)

ConforMIS

Patients with ConforMIS implants

Standard Total Knee Implant

Patients implanted with standard total knee implant

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are at least 6 month post-op with a ConforMIS knee replacement or a standard total knee replacement who meets the inclusion/exclusion criteria

You may qualify if:

• At least 6 months post-op with no other surgical procedures conducted within the past 6 months
• Between 40-70 years of age
• Body weight of less than 250lbs
• BMI of less than 38
• Pregnant females will be excluded
• TKA patients will be judged Clinically successful with an American Knee Society score of greater than 90
• Must have 100 degrees post-op passive flexion with no ligamentous laxity or pain
• Participants must be able to walk on level ground without aid of any kind and ascend/descend stairs without assistance.
• All potential subjects will have either a personalized ConforMIS™ TKA or a traditional TKA manufactured by an orthopaedic company other than ConforMIS.
• Patients from the physician's list who do not meet the study requirements will not be considered.
• Patients must be willing to sign the Informed Consent and HIPAA forms to participate in the study.
• Patients must be between 160cm (5'3) and 193cm (6'4) tall.

Sponsors & Collaborators

• Restor3D: lead

Study Sites (2)

University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

Tennessee Orthopedic Alliance

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Rebecca Robertson
• Organization: University of Tennessee

rrober28@utk.edu

865-974-2093

Study Officials

• Richard D Komistek, PhD

  Univeristy of Tennessee

  PRINCIPAL INVESTIGATOR

• William Kurtz, MD

  Tennessee Orthopedic Alliance

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2012
• First Posted: October 30, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 25, 2023
• Results First Posted: December 31, 2020

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)