Stability of the Medial Pivot Total Knee Prosthesis

NCT02577978 | Completed Results

• 1 other identifier: STU00090745
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare objective and subjective measures of knee stability following total knee arthroplasty with a medial pivot design vs. a posterior stabilized design.

Conditions

Osteoarthritis of Knee

Outcome Measures

Primary Outcomes (10)

• Oxford Knee Score (OKS) Pre-operative Through 2 Years Post-operative

  Patient completed Oxford Knee Score questionnaire used to assess the patient's perspective of outcome following Total Knee Arthroplasty (TKA); score range is reported between 0-48 with improvement in outcomes reflected as a higher numerical value (e.g. a 'complete' return to pre-disease functionality would be reported as a score of 48)

  Pre-operatively on day of surgery, 6 weeks, 3 months, 6 months, 12 months and 24 months post-operatively

• Veteran's RAND 12 (VR-12) Mental Composite Score (MCS) Through 2 Years Post Operative

  Veteran's RAND 12 Item Health Survey used to assess health-related quality of life, to estimate disease burden, and to evaluate disease-specific benchmarks. Scores for the Mental Composite Score (MCS) range from 5.2 to 76.3 and are evaluated as a summative T-score with population mean of 50 (Standard Deviation = 10);higher scores indicate improved mental wellness/function as reported by patients.

  Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.

• Veteran's RAND 12 (VR-12) Physical Composite Score (PCS) Through 2 Years Post Operative

  Veteran's RAND 12 Item Health Survey used to assess health-related quality of life, to estimate disease burden, and to evaluate disease-specific benchmarks. Scores for the Physical Composite Score (MCS) range from 6.3 to 71.8 and are evaluated as a summative T-score with population mean of 50 (Standard Deviation = 10);higher scores indicate improved physical wellness/function as reported by patients.

  Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.

• PROMIS Computerized Adaptive Tests (CATs) for Physical Function Through 2 Years Post-operative

  Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Physical Function domain higher scores indicated improved physical function as reported by the patient

  Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.

• PROMIS Computerized Adaptive Tests (CATs) for Pain Interference Through 2 Years Post-operative

  Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Pain Interference domain an increased value indicates greater severity/frequency of pain reported by the patient.

  Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.

• PROMIS Computerized Adaptive Tests (CATs) for Pain Behavior Through 2 Years Post-operative

  Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Pain Behavior domain an increased value indicates greater severity/frequency of pain reported by the patient

  Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.

• Total Score Calculated Using the Forgotten Joint Score in Order to Assess the Subject's Ability to Forget the Artificial Joint in Everyday Life

  Patient completed questionnaire used to assess the patients' ability to forget about a joint as a result of successful treatment. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60 where a high score indicates an improved outcome. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score with higher scores indicating improved physical function/reduced impact of symptoms on activity: Final score = 100 - ((sum(item01 to item12) - 12)/48\*100)

  12 months post-operatively

• International Knee Documentation Committee (IKDC) Questionnaire Assessed Through 2 Years Post-op

  The International Knee Documentation Committe (IKDC) Questionnaire is a subjective scale that provides patients with an overall function score based on a summative score for 3 sub categories (knee function, sports activities, pain/symptoms). A score between 0-100 is obtained as the sum of scores for each individual question, with increasing composite scores correlating positively with patient functional status/quality of life.

  Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.

• Score for the Knee Society Score (KSS) Knee Component at 1 Year Post-operatively

  Physician completed Knee Society Score questionnaire used to measure a patient's functional ability before and after total knee arthroplasty (TKA); score range is reported between 0-100 with improvement in outcomes reflected as a higher numerical value (e.g. a 'complete' return to pre-disease functionality would be reported as a score of 100)

  12 months post-operatively

• Score for the Knee Society Score (KSS) Function Component at 1 Year Post-operatively

  Physician completed Knee Society Score questionnaire used to measure a patient's functional ability before and after total knee arthroplasty (TKA); score range is reported between 0-100 with improvement in outcomes reflected as a higher numerical value (e.g. a 'complete' return to pre-disease functionality would be reported as a score of 100)

  12 months post-operatively

Secondary Outcomes (3)

• Assessing Knee Stability Using the KT-1000 Arthrometer (at 30 Degrees)

  1 year post-operatively

• Assessing Knee Stability Using the KT-1000 Arthrometer (at 90 Degrees)

  1 year post-operatively

• Get-up-and-Go Test

  Between 6 months and 1 year post-operatively

Study Arms (2)

Medacta Sphere

OTHER

Ball-and-socket

Device: Medacta GMK Sphere prosthesis

Medacta PS

OTHER

Cam-and-post

Device: Medacta GMK posterior stabilized prosthesis

Interventions

Medacta GMK posterior stabilized prosthesis DEVICE

Medacta PS

Medacta GMK Sphere prosthesis DEVICE

Medacta Sphere

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85, regardless of gender, ethnicity, or pathology
• Must require a total knee arthroplasty
• All subjects must have given signed, informed consent prior to registration in study.

You may not qualify if:

• Minors
• Any patients that are unable to consent
• Patients with active infection or osseous tumor of the operative extremity
• Patients undergoing revision surgery

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Medicine Department of Orthopaedic Surgery

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: David W Manning
• Organization: Northwestern Medicine

David.Manning@nm.org

3124726023

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 16, 2015
• Study Start: April 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 19, 2023
• Results First Posted: May 29, 2019

Record last verified: 2023-05

Locations

US (1)