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

NCT02339610 | Completed

• 1 other identifier: 13005
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 4

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).

Conditions

Non-inflammatory Degenerative Joint Disease

Keywords

Osteoarthritis; Post-traumatic Arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  6 Months Post-Operative minus Pre-Op

Secondary Outcomes (4)

• KOOS-PS change from baseline of the ATTUNE knee

  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

• Length of Hospital Stay

  Immediate-post-operative: average 1 week

• Annual Survivorship

  1 year (304 - 669 days), 2 years (670 - 913 days) post-operative

• Type and frequency of Adverse Events (AEs) for all enrolled subjects

  Day 0 - Post-Operative Day 913

Study Arms (1)

ATTUNE Primary, Cemented Total Knee Replacement

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

Device: ATTUNE Primary, Cemented Total Knee Replacement

Interventions

ATTUNE Primary, Cemented Total Knee Replacement DEVICE

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).

ATTUNE Primary, Cemented Total Knee Replacement

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DePuy Orthopaedics: lead

Study Sites (4)

Rijnstate Hospital - Orthopaedic Department

Arnhem, Gelderland, 6800, Netherlands

Location

Lievensberg Hospital Orthopaedic Department

Bergen op Zoom, North Brabant, 4624, Netherlands

Location

Spaarne Hospital Orthopaedic Department

Hoofddorp, North Holland, 2134, Netherlands

Location

HAGA Hospital Orthopaedic Department

The Hague, South Holland, 2566, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 33864173 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Verdonna Huey, MS, BSN, CCRP

  DePuy Orthopaedics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: January 15, 2015
• Study Start: January 1, 2015
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

NL (4)