14022 ATTUNE Cementless RP Clinical Performance Evaluation

Study Purpose

The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 22 Years - 80 Years
Gender All
More Inclusion & Exclusion 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 NIDJD.
  • - Subject, in the opinion of the Investigator, is a suitable candidate for cementless primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
  • - Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the 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 read, and comprehend the Informed Consent Document as well as complete the required PROs in either English or one of the available 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 diagnosed with 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 (3) 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 five (5) years life expectancy.
- Uncontrolled gout

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02839850
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

DePuy Orthopaedics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Sue Kemp, B.Sc., Ph.D.
Principal Investigator Affiliation Sponsor GmbH
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Austria, Canada, France, Germany, Ireland, Netherlands, New Zealand, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis
Additional Details

The secondary objectives of this study are:

  • - Evaluate change from preoperative baseline in post-operative outcomes using additional patient reported measures at 2 years: PKIP (overall and sub-scores), KOOS (overall and sub-scores), AKS and EQ-5D-3L.
  • - Evaluate change from preoperative baseline in pain and satisfaction over time as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale) at 2yr.
  • - Evaluate type and frequency of Adverse Events - Evaluate survivorship of the ATTUNE Primary Cementless TKA system for the CR RP and PS RP configurations using Kaplan-Meier survival analysis at 2yr and 5yrs.
  • - Evaluate primary, cementless ATTUNE TKA fixation through zonal radiographic analysis of the bone-implant interface at 6wk, 6mo, 1yr, and 2yr after surgery.
  • - Evaluate any changes in anatomic tibiofemoral, femoral component and tibial component alignment at 2 years compared to the first postoperative radiographs.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Newport News, Virginia

Status

Active, not recruiting

Address

Hampton Roads Orthopaedics and Sports Medicine

Newport News, Virginia, 23606

Site Contact

skemp1@ITS.JNJ.com

Lubbock, Texas

Status

Active, not recruiting

Address

Texas Tech University Heath Science Center

Lubbock, Texas, 49416

Site Contact

skemp1@ITS.JNJ.com

Associated Orthopaedics of Kingsport, Kingsport, Tennessee

Status

Recruiting

Address

Associated Orthopaedics of Kingsport

Kingsport, Tennessee, 37660

Site Contact

skemp1@ITS.JNJ.com

UNC Chapel Hill, Chapel Hill, North Carolina

Status

Recruiting

Address

UNC Chapel Hill

Chapel Hill, North Carolina, 27599

Site Contact

skemp1@ITS.JNJ.com

SUNY downstate Medical Center, Brooklyn, New York

Status

Not yet recruiting

Address

SUNY downstate Medical Center

Brooklyn, New York, 11203

Site Contact

skemp1@ITS.JNJ.com

Rothman Institute, Egg Harbor Township, New Jersey

Status

Not yet recruiting

Address

Rothman Institute

Egg Harbor Township, New Jersey, 08234

Site Contact

skemp1@ITS.JNJ.com

New London Hospital, New London, New Hampshire

Status

Active, not recruiting

Address

New London Hospital

New London, New Hampshire, 03257

Site Contact

skemp1@ITS.JNJ.com

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

Site Contact

skemp1@ITS.JNJ.com

Florida Research Associates, DeLand, Florida

Status

Recruiting

Address

Florida Research Associates

DeLand, Florida, 32720

Site Contact

skemp1@ITS.JNJ.com

Colorado Joint Replacement, Denver, Colorado

Status

Recruiting

Address

Colorado Joint Replacement

Denver, Colorado, 80210

Site Contact

skemp1@ITS.JNJ.com

International Sites

Nottingham, United Kingdom

Status

Not yet recruiting

Address

Nottingham University Hospitals NHS Trust

Nottingham, , NG5 1PB

Site Contact

skemp1@ITS.JNJ.com

Wrightington Hospital, Wigan, Lancashire, United Kingdom

Status

Active, not recruiting

Address

Wrightington Hospital

Wigan, Lancashire, WN6 9EP

Site Contact

skemp1@ITS.JNJ.com

University of Otago, Christchurch, New Zealand

Status

Active, not recruiting

Address

University of Otago

Christchurch, , 8083

Site Contact

skemp1@ITS.JNJ.com

Elkerliek Ziekenhuis, Helmond, Noord-Brabant, Netherlands

Status

Recruiting

Address

Elkerliek Ziekenhuis

Helmond, Noord-Brabant, 5707 HA

Site Contact

skemp1@ITS.JNJ.com

Cork, Ireland

Status

Recruiting

Address

South Infirmary Victoria University Hospital

Cork, , T12 X23H

Site Contact

skemp1@ITS.JNJ.com

Klinikum Garmisch-Partenkirchen GmbH, Garmisch-Partenkirchen, Germany

Status

Active, not recruiting

Address

Klinikum Garmisch-Partenkirchen GmbH

Garmisch-Partenkirchen, , 82467

Site Contact

skemp1@ITS.JNJ.com

Salouel, France

Status

Recruiting

Address

Sevice de Chirurgie Orthoedique et Traumatologique

Salouel, , 80480

Site Contact

skemp1@ITS.JNJ.com

CHU de la Cavale Blanche, Brest, Cedex, France

Status

Recruiting

Address

CHU de la Cavale Blanche

Brest, Cedex, 29285

Site Contact

Frederic Dubrana

Frederic.dubrana@chu-brest.fr

+33607597865

Calgary, Alberta, Canada

Status

Recruiting

Address

Foothills Medical Centre, University of Calgary

Calgary, Alberta, T2N 2T9

Site Contact

Shannon Puloski

spuloski@ucalgary.ca

403-944-8635

Ried im Innkreis, Upper Austria, Austria

Status

Active, not recruiting

Address

Krankenhaus der Barmherzigen Schwestern Ried im Innkreis

Ried im Innkreis, Upper Austria, 4910

Site Contact

skemp1@ITS.JNJ.com

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