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Evaluation of Post-Operative Recovery in ATTUNE® Total Knee Arthroplasty

Primary Purpose

Non-inflammatory Degenerative Joint Disease

Status
Completed
Phase
Locations
Netherlands
Study Type
Observational
Intervention
ATTUNE Primary, Cemented Total Knee Replacement
Sponsored by
DePuy Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Non-inflammatory Degenerative Joint Disease focused on measuring Osteoarthritis, Post-traumatic Arthritis

Eligibility Criteria

22 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive.
  • Subject was diagnosed with Non-inflammatory Degenerative Joint Disease (NIDJD).
  • Subject is a suitable candidate for cemented primary total knee replacement (TKA) using the devices described in this protocol with either resurfaced or non-resurfaced patellae.
  • Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to the study Sponsor.
  • Subject is currently not bedridden
  • Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow- up visits and co-operate with investigational procedures.
  • Subject is able to speak, read, and comprehend the Informed Consent Document as well as complete the Patient Reported Outcomes Questionnaires required per the protocol in either Dutch or English translations.

Exclusion Criteria:

  • The Subject is a woman who is pregnant or lactating.
  • Contralateral knee has already been enrolled in this study .
  • Subject had a contralateral amputation.
  • Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
  • Subject is currently experiencing radicular pain from the spine that radiates into the limb to receive TKA.
  • Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
  • Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
  • Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
  • Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
  • Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease).
  • Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).
  • Subject has a medical condition with less than 3 years of life expectancy.

Sites / Locations

  • Rijnstate Hospital - Orthopaedic Department
  • Lievensberg Hospital Orthopaedic Department
  • Spaarne Hospital Orthopaedic Department
  • HAGA Hospital Orthopaedic Department

Arms of the Study

Arm 1

Arm Type

Arm Label

ATTUNE Primary, Cemented Total Knee Replacement

Arm Description

Subjects will receive one of four available ATTUNE total knee implants: (CR FB, CR RP, PS FB, PS RP).

Outcomes

Primary Outcome Measures

KOOS-PS change from baseline at 6 months post-operatively, as estimated from a repeated measurements longitudinal model over all post-operative time points.
The Knee Injury and Osteoarthritis Physical Function Short Form (KOOS-PS) will be used to measure knee function as a means of evaluating the rate of recovery. The (KOOS-PS) is a patient self-administered questionnaire. The questionnaire consists of 7 questions to evaluate function with activities of daily living (ADL) and higher level functioning activities (sport and recreational). Each question has 5 Likert-like response options. Scoring is a 0-100 point scale with 100 points considered best.

Secondary Outcome Measures

KOOS-PS change from baseline of the ATTUNE knee
The Knee Injury and Osteoarthritis Physical Function Short Form (KOOS-PS) will be used to measure knee function as a means of evaluating the rate of recovery. The (KOOS-PS) is a patient self-administered questionnaire. The questionnaire consists of 7 questions to evaluate function with activities of daily living (ADL) and higher level functioning activities (sport and recreational). Each question has 5 Likert-like response options. Scoring is a 0-100 point scale with 100 points considered best.
Length of Hospital Stay
Collect days of hospitalization related to TKA procedure
Annual Survivorship
A Kaplan-Meier survival analysis will be used to calculate the survivorship of the ATTUNE implant.
Type and frequency of Adverse Events (AEs) for all enrolled subjects
All Serious AEs must be reported to the Sponsor per protocol. All device-related and/or procedure-related AEs must be reported to the Sponsor per protocol.

Full Information

First Posted
November 21, 2014
Last Updated
August 22, 2019
Sponsor
DePuy Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT02339610
Brief Title
Evaluation of Post-Operative Recovery in ATTUNE® Total Knee Arthroplasty
Official Title
Multi-Center Evaluation of Post-Operative Recovery in ATTUNE Primary, Cemented Total Knee Arthroplasty
Study Type
Observational

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
June 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy Orthopaedics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This post-marketing investigation will evaluate the rate of recovery of the ATTUNE knee from the time of surgery through the 6 month endpoint in patients with severely painful and/or severely disabling Non-inflammatory Degenerative Joint Disease (NIDJD).
Detailed Description
This study is designed as a prospective, multi-center, non-randomized, non-comparative, non-controlled study. A sample size of N=200 subjects will be implanted at up to 4 sites in the Netherlands. Each site is expected to implant approximately 50 Subjects (50 knees). This study allows the participating surgeon to choose the type of ATTUNE implant they would ordinarily use in standard practice. Both resurfaced patellae and non-resurfaced patellae are permitted in this investigation; consistent with the surgeons standard of care. Subjects will receive one of four available implants: cruciate retaining fixed bearing (CR FB), cruciate retaining rotating platform (CR RP), posterior stabilized fixed bearing (PS FB), and posterior stabilized rotating platform (PS RP).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-inflammatory Degenerative Joint Disease
Keywords
Osteoarthritis, Post-traumatic Arthritis

7. Study Design

Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ATTUNE Primary, Cemented Total Knee Replacement
Arm Description
Subjects will receive one of four available ATTUNE total knee implants: (CR FB, CR RP, PS FB, PS RP).
Intervention Type
Device
Intervention Name(s)
ATTUNE Primary, Cemented Total Knee Replacement
Intervention Description
Patients will undergo a primary total knee replacement using one of the four implant configurations of the ATTUNE knee ( CR FB, CR RP, PS FB, PS RP).
Primary Outcome Measure Information:
Title
KOOS-PS change from baseline at 6 months post-operatively, as estimated from a repeated measurements longitudinal model over all post-operative time points.
Description
The Knee Injury and Osteoarthritis Physical Function Short Form (KOOS-PS) will be used to measure knee function as a means of evaluating the rate of recovery. The (KOOS-PS) is a patient self-administered questionnaire. The questionnaire consists of 7 questions to evaluate function with activities of daily living (ADL) and higher level functioning activities (sport and recreational). Each question has 5 Likert-like response options. Scoring is a 0-100 point scale with 100 points considered best.
Time Frame
6 Months Post-Operative minus Pre-Op
Secondary Outcome Measure Information:
Title
KOOS-PS change from baseline of the ATTUNE knee
Description
The Knee Injury and Osteoarthritis Physical Function Short Form (KOOS-PS) will be used to measure knee function as a means of evaluating the rate of recovery. The (KOOS-PS) is a patient self-administered questionnaire. The questionnaire consists of 7 questions to evaluate function with activities of daily living (ADL) and higher level functioning activities (sport and recreational). Each question has 5 Likert-like response options. Scoring is a 0-100 point scale with 100 points considered best.
Time Frame
Pre-Op (-90 days to day of surgery), 6 weeks (1 - 60 days), 3 months (61 - 137 days), 1 year (304 - 669 days), and 2 years (670 - 913 days) post-operative
Title
Length of Hospital Stay
Description
Collect days of hospitalization related to TKA procedure
Time Frame
Immediate-post-operative: average 1 week
Title
Annual Survivorship
Description
A Kaplan-Meier survival analysis will be used to calculate the survivorship of the ATTUNE implant.
Time Frame
1 year (304 - 669 days), 2 years (670 - 913 days) post-operative
Title
Type and frequency of Adverse Events (AEs) for all enrolled subjects
Description
All Serious AEs must be reported to the Sponsor per protocol. All device-related and/or procedure-related AEs must be reported to the Sponsor per protocol.
Time Frame
Day 0 - Post-Operative Day 913

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive. Subject was diagnosed with Non-inflammatory Degenerative Joint Disease (NIDJD). Subject is a suitable candidate for cemented primary total knee replacement (TKA) using the devices described in this protocol with either resurfaced or non-resurfaced patellae. Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to the study Sponsor. Subject is currently not bedridden Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow- up visits and co-operate with investigational procedures. Subject is able to speak, read, and comprehend the Informed Consent Document as well as complete the Patient Reported Outcomes Questionnaires required per the protocol in either Dutch or English translations. Exclusion Criteria: The Subject is a woman who is pregnant or lactating. Contralateral knee has already been enrolled in this study . Subject had a contralateral amputation. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee. Subject is currently experiencing radicular pain from the spine that radiates into the limb to receive TKA. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims. Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements. Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia. Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease). Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.). Subject has a medical condition with less than 3 years of life expectancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Verdonna Huey, MS, BSN, CCRP
Organizational Affiliation
DePuy Orthopaedics
Official's Role
Study Director
Facility Information:
Facility Name
Rijnstate Hospital - Orthopaedic Department
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6800
Country
Netherlands
Facility Name
Lievensberg Hospital Orthopaedic Department
City
Bergen op Zoom
State/Province
North Brabant
ZIP/Postal Code
4624
Country
Netherlands
Facility Name
Spaarne Hospital Orthopaedic Department
City
Hoofddorp
State/Province
North Holland
ZIP/Postal Code
2134
Country
Netherlands
Facility Name
HAGA Hospital Orthopaedic Department
City
The Hague
State/Province
South Holland
ZIP/Postal Code
2566
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
33864173
Citation
van Loon C, Baas N, Huey V, Lesko J, Meermans G, Vergroesen D. Early outcomes and predictors of patient satisfaction after TKA: a prospective study of 200 cases with a contemporary cemented rotating platform implant design. J Exp Orthop. 2021 Apr 17;8(1):30. doi: 10.1186/s40634-021-00347-w.
Results Reference
derived

Learn more about this trial

Evaluation of Post-Operative Recovery in ATTUNE® Total Knee Arthroplasty

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