Who is sponsoring NCT03427047?

NCT03427047 is sponsored by Medacta USA.

What drugs are being tested in NCT03427047?

Interventions in NCT03427047: MyKnee with single use Efficiency Instrument, Stryker Navigational with conventional metal instruments.

What condition does NCT03427047 study?

NCT03427047 studies Osteo Arthritis Knee, Total Knee Arthroplasty.

Is NCT03427047 still recruiting?

NCT03427047 is currently completed. Last updated 13 June 2023.

Are results published for NCT03427047?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-06-13 · How we verify

NCT03427047

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Comparing Surgical and Economical Parameters of Total Knee Replacement.

Completed NA Results posted Last updated 13 June 2023

What this trial tests

NA trial testing MyKnee with single use Efficiency Instrument in Osteo Arthritis Knee in 82 participants. Completed in 1 January 2022.

Timeline

1 August 2018

Primary endpoint
1 January 2022

1 January 2022

Quick facts

Lead sponsor	Medacta USA
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	82
Start date	1 August 2018
Primary completion	1 January 2022
Estimated completion	1 January 2022
Sites	1 location across United States

Drugs / interventions tested

MyKnee with single use Efficiency Instrument
Stryker Navigational with conventional metal instruments

Conditions studied

Osteo Arthritis Knee — all drugs for Osteo Arthritis Knee →
Total Knee Arthroplasty — all drugs for Total Knee Arthroplasty →

Sponsor

Medacta USA

Who can join

Adults 16 to 75, any sex, with Osteo Arthritis Knee or Total Knee Arthroplasty. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Compare Time-saving Associated With the Two Procedures. Primary · Day of surgery

Measure clean up time at end of surgery in minutes

Group	Value	95% CI
MyKnee With Single Use Efficiency Instrument	25.12	8.00 – 52.33
Stryker Navigational With Conventional Metal Instruments	28.47	10.00 – 130.10

Patient OR Time From Both Study Arms Primary · Day of surgery

Measure skin to skin, tourniquet time and femoral and tibial resection time in minutes

incision to closure time

Group	Value	95% CI
MyKnee With Single Use Efficiency Instrument	69.83	51.47 – 97.32
Stryker Navigational With Conventional Metal Instruments	70.44	58.42 – 82.82

tourniquet time

Group	Value	95% CI
MyKnee With Single Use Efficiency Instrument	53.07	41.98 – 78.48
Stryker Navigational With Conventional Metal Instruments	52.84	27.25 – 92.03

femur and tibia time

Group	Value	95% CI
MyKnee With Single Use Efficiency Instrument	10.98	4.68 – 30.08
Stryker Navigational With Conventional Metal Instruments	11.87	0.83 – 19.80

Estimated Blood Loss From Both Study Arms Secondary · Day of surgery

Volume of estimated blood loss in cc's

Group	Value	95% CI
MyKnee With Single Use Efficiency Instrument	105.43	50 – 200
Stryker Navigational With Conventional Metal Instruments	100	50 – 200

Baseline of Hemoglobin Both Study Arms Secondary · Baseline, 1 day post-op or at discharge from hospital

Measure in grams per deciliter

Baseline

Group	Value	95% CI
MyKnee With Single Use Efficiency Instrument	14.18	12.20 – 16.30
Stryker Navigational With Conventional Metal Instruments	13.77	11.40 – 15.70

Post-op

Group	Value	95% CI
MyKnee With Single Use Efficiency Instrument	12.57	10.70 – 15.20
Stryker Navigational With Conventional Metal Instruments	12.31	9.60 – 15.60

Volume of Transfusions Both Study Arms Secondary · Day of surgery

Measure amount of blood patient receives in ML

Group	Value	95% CI
MyKnee With Single Use Efficiency Instrument	0	0 – 0
Stryker Navigational With Conventional Metal Instruments	0	0 – 0

Instrument Trays Sent to Sterilization Both Study Arms Secondary · Day of surgery

Record number of trays sent to be sterilized

Group	Value	95% CI
MyKnee With Single Use Efficiency Instrument	5.48	3 – 7
Stryker Navigational With Conventional Metal Instruments	9.5	7 – 20

Amount of Waste From Surgery Both Study Arms Secondary · Day of surgery

Combined weight of recyclable and non-recyclable waste in grams

Group	Value	95% CI
MyKnee With Single Use Efficiency Instrument	20196.7	14242.8 – 27442.3
Stryker Navigational With Conventional Metal Instruments	17653.5	13108.8 – 20910.6

Baseline of Mechanical Axis Both Study Arms Secondary · Baseline, post-operative 6 weeks

Determine radiographic analysis by measuring knee mechanical axis in degrees

Baseline

Group	Value	95% CI
MyKnee With Single Use Efficiency Instrument	6.05	0 – 12
Stryker Navigational With Conventional Metal Instruments	5.71	0 – 15

Post-operative 6 weeks

Group	Value	95% CI
MyKnee With Single Use Efficiency Instrument	1.64	0 – 6
Stryker Navigational With Conventional Metal Instruments	1.24	0 – 7

Change From Baseline of Tibial Slope Both Study Arms Secondary · Baseline, post-operative 6 weeks

Determine radiographic analysis by measuring tibial angles in degrees

Baseline

Group	Value	95% CI
MyKnee With Single Use Efficiency Instrument	3.80	0 – 12
Stryker Navigational With Conventional Metal Instruments	2.08	0 – 8

Post-operative 6 weeks

Group	Value	95% CI
MyKnee With Single Use Efficiency Instrument	1.8	0 – 8
Stryker Navigational With Conventional Metal Instruments	1.87	0 – 4

Related Complications Secondary · Baseline, day of surgery, post-op 6 weeks

Assess adverse events and serious adverse events related to both procedures

Group	Value	95% CI
MyKnee With Single Use Efficiency Instrument	0
Stryker Navigational With Conventional Metal Instruments	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 weeks post-op. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MyKnee With Single Use Efficiency Instrument

Serious: 0/46 (0%)

Deaths: 0/46

Stryker Navigational With Conventional Metal Instruments

Serious: 0/36 (0%)

Deaths: 0/36

Other adverse events (4 terms — click to expand)

Reaction	System	MyKnee With Single Use Eff…	Stryker Navigational With …
Acute posterior knee pain	Musculoskeletal and connective tissue disorders	—	—
Deep Vein Thrombosis	Vascular disorders	—	—
Weepy Left Knee Incision	Surgical and medical procedures	—	—
Extremely stiff with swelling and pain	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT03427047 adverse events section.

Sponsor's own description

Randomized study comparing surgical and economic parameter of Total Knee Arthroplasty performed using two different specific surgical techniques.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Osteo Arthritis Knee

Currently open trials in the same condition.

NCT07258693 — Multimodal Treatment of Knee Osteoarthritis: Therapeutic Exercise and Noninvasive Neuromodulation (NESA) Versus Therapeu · NA · active not recruiting
NCT07141316 — Effects of Blood Flow Restriction Combined With Electrostimulation After Knee Arthroplasty · NA · active not recruiting
NCT06485843 — An Study to Evaluate Safety and Tolerability of OA-SYS in Subjects With Moderate to Severe Osteoarthritis of the Knee Jo · Phase 2 · recruiting
NCT06965946 — Intermittent Hypoxia-Hyperoxia Combined With Physical Therapy for Knee Osteoarthritis · NA · recruiting
NCT06058169 — Effects of Home Base Whole-body Vibration in Osteoarthritis. (VIBE-Rx2) · NA · recruiting

Other Medacta USA trials

Trials by the same sponsor.

NCT05721859 — M-Vizion™ Macroscopic Radiographic Study · recruiting
NCT05461638 — Kinematic Alignment vs Mechanical Alignment for Total Knee Arthroplasty · NA · withdrawn
NCT03148379 — Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Co · NA · completed
NCT03211663 — Performance of MOTO Medial® Unicompartmental Knee Arthroplasty · active not recruiting
NCT03168750 — Analysis of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03427047 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medacta USA
Last refreshed: 13 June 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03427047.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03427047

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Osteo Arthritis Knee

Other Medacta USA trials

Verify against primary sources