ATTUNE Single-Use Instrumentation vs. ATTUNE Reusable Instrumentation in Primary Total Knee Arthroplasty

Comparison of Alignment Achieved Using Single-Use Versus Reusable Instrumentation in Total Knee Arthroplasty (TKA): A Prospective, Non-Randomized Multi-center Investigation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02574312

Acronym

SOLO

Enrollment

Registered

2015-10-12

Start date

2015-10-01

Completion date

2019-03-28

Last updated

2020-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Post-traumatic Arthritis

Keywords

Mechanical Axis Alignment, Knee Arthroplasty, Total

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.

Interventions

DEVICEATTUNE TKA with ATTUNE RUI

ATTUNE TKA with ATTUNE RUI

DEVICEATTUNE TKA with ATTUNE SUI

ATTUNE TKA with ATTUNE SUI

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

22 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Difference in Absolute Mechanical Axis Alignment Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation	3 Months Post Surgery

Secondary

Measure	Time frame
Femoral Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation	3 Months Post Surgery
Tibial Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation	3 Months Post Surgery
Femoral Component Flexion Angle Between Subjects Operated on With RUI and SUI Instrumentation	3 Months Post Surgery
Posterior Tibial Slope Between Subjects Operated on With RUI and SUI Instrumentation	3 Months Post Surgery
Number of Participants With Treatment-related Adverse Events	3 Months Post Surgery

Countries

United Kingdom, United States

Participant flow

Recruitment details

The first patient was operated on 16 November 2015 and recruitment lasted for 37 months with the last patient operated on 19 December 2018.

Pre-assignment details

Consent was taken for 102 knees, 14 subjects were deemed ineligible for the study. This left 88 subjects in the safety population that could be randomised for the study.

Participants by arm

Arm	Count
RUI (Reuseable Instrumentation) Patients were operated on using Reusable TKA Instrumentation	44
SUI (Single-Use Instrumentation) Patients were operated on using Single-Use TKA Instrumentation	44
Total	88

Withdrawals & dropouts

Period	Reason	FG000	FG001
3 Months Follow-up	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	SUI (Single-Use Instrumentation)	Total	RUI (Reuseable Instrumentation)
Age, Continuous	69.3 years STANDARD_DEVIATION 7.98	67.9 years STANDARD_DEVIATION 8	66.0 years STANDARD_DEVIATION 6.89
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants	44 Participants	22 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	22 Participants	44 Participants	22 Participants
Region of Enrollment United Kingdom	22 Participants	44 Participants	22 Participants
Region of Enrollment United States	22 Participants	44 Participants	22 Participants
Sex: Female, Male Female	26 Participants	46 Participants	20 Participants
Sex: Female, Male Male	18 Participants	42 Participants	24 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 44	0 / 44
other Total, other adverse events	5 / 44	2 / 44
serious Total, serious adverse events	1 / 44	0 / 44