Clinical trial NCT02574312: ATTUNE Single-Use Instrumentation vs. ATTUNE Reusable Instrumentation in Primary Total Knee Arthroplasty
Official title: Comparison of Alignment Achieved Using Single-Use Versus Reusable Instrumentation in Total Knee Arthroplasty (TKA): A Prospective, Non-Randomized Multi-center Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Post-traumatic Arthritis
Keywords: Mechanical Axis Alignment
Knee Arthroplasty, Total
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2015-10-12
Enrollment: 88
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This post-marketing investigation will evaluate the mechanical axis alignment achieved with the ATTUNE Single-Use Instrumentation (SUI) as compared to the mechanical axis alignment achieved with the ATTUNE Reusable Instrumentation (RUI) in primary cemented Total Knee Arthroplasty.

Detailed description: This study is designed as comparative, sequential, non-randomized, multi-center investigation.

Up to four sites will recruit approximately 88 subjects. Each site is expected to implant the ATTUNE primary cemented total knee in approximately 22 subjects. The sequential design requires all ATTUNE TKA with reusable instruments be completed before doing any ATTUNE TKA with single use instruments.

The mechanical axis alignment will be assessed at the 3 month follow-up by independent radiographic review.

Eligibility criteria: Inclusion Criteria:

1. Subjects with severely painful and/or severely disabling Non-inflammatory Degenerative Joint Disease (NIDJD) resulting from osteoarthritis (OA) or post-traumatic arthritis.
2. Subject is male or female and between the ages of 22 and 80 years old, inclusive.
3. Subject requires a primary total knee replacement and is considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol.
4. Subject, who, in the opinion of the Investigator, is suitable for implantation using either RUI or SUI instrumentation.
5. Subject is able to speak and read English to facilitate comprehension of the Informed Consent Document.
6. Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy Synthes Joint Reconstruction.
7. 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.

Exclusion Criteria:

1. The Subject has, in the opinion of the Investigator, a severe deformity that will hinder achieving a mechanical axis alignment target of 0° ± 3°.
2. The Subject has, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study.
3. The Subject has, in the opinion of the Investigator, a flexion deformity that will not allow for 0° extension postoperatively.
4. The Subject is a woman who is pregnant or lactating.
5. The 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 follow-up care or treatment outcomes.
6. The Subject has participated in a clinical investigation with an investigational product in the last 3 months.
7. The Subject is currently involved in any personal injury litigation, medical-legal or worker's compensations claims.
8. The Subject has previous prosthetic knee replacement (any type including unicompartmental, total knee arthroplasty, patellofemoral arthroplasty or ipsilateral UTO/HTO) of the affected knee or a previous patellectomy.
9. The Subject presents with ankylosis of the hip joint on the side to be treated.
10. The Subject had a contralateral TKA and that knee was previously entered into the study.
11. The Subject requires simultaneous bilateral total knee replacements.
12. Any case in which Computer-Assisted Surgery (CAS) or TruMatch (or any other type of Custom Patient Instruments) is to be used, or any additional instrumentation are to be used for bone resections that are not provided as part of the ATTUNE RUI or SUI Instrument kits.
13. The Subject requires a device not specified in the protocol or the surgeon determines that the ATTUNE Knee System is not a suitable treatment.

Primary outcomes:
measure: Difference in Absolute Mechanical Axis Alignment Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation
timeFrame: 3 Months Post Surgery
Secondary outcomes:
measure: Femoral Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation
timeFrame: 3 Months Post Surgery
measure: Tibial Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation
timeFrame: 3 Months Post Surgery
measure: Femoral Component Flexion Angle Between Subjects Operated on With RUI and SUI Instrumentation
timeFrame: 3 Months Post Surgery
measure: Posterior Tibial Slope Between Subjects Operated on With RUI and SUI Instrumentation
timeFrame: 3 Months Post Surgery
measure: Number of Participants With Treatment-related Adverse Events
timeFrame: 3 Months Post Surgery
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic Torrey Pines
state: California
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley
state: Pennsylvania
city: Liverpool
country: United Kingdom
facility: Spire Liverpool Hospital
city: York
country: United Kingdom
facility: Clifton Park Hospital
Study officials:
affiliation: DePuy Synthes
name: Verdonna Huey, MS,BSN,CCRP
role: STUDY_DIRECTOR
References: