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

NCT ID: NCT02339610

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2019-06-28

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).

Conditions

Non-inflammatory Degenerative Joint Disease

Study Groups

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).

ATTUNE Primary, Cemented Total Knee Replacement

Intervention Type: 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).

Interventions

ATTUNE Primary, Cemented Total Knee Replacement

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).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Verdonna Huey, MS, BSN, CCRP

Role: STUDY_DIRECTOR

DePuy Orthopaedics

Locations

Rijnstate Hospital - Orthopaedic Department

Arnhem, Gelderland, Netherlands

Lievensberg Hospital Orthopaedic Department

Bergen op Zoom, North Brabant, Netherlands

Spaarne Hospital Orthopaedic Department

Hoofddorp, North Holland, Netherlands

HAGA Hospital Orthopaedic Department

The Hague, South Holland, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 33864173 (View on PubMed)

Other Identifiers

13005

Identifier Type: -

Identifier Source: org_study_id