A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen Total Knee System in Total Knee Arthroplasty
Phase: NA
Conditions: Osteoarthritis, Knee
Sponsor: Zimmer Biomet

 
 
 
Multicenter Prospective Randomized Control Study on Persona Total 
Knee System vs NexGen Total Knee System in Total Knee Arthroplasty 
 
K.CR.I.EU.15.13 
Protocol no.: 1.05 
November 28th, 2016 
 
Primary investigator 
Anders Troelsen, MD, Professor. (1) (Surgeon) 
Kirill Gromov, MD  (1) (Surgeon) 
Investigators 
Henrik Husted, MD (1) (Surgeon) 
Per Wagner Kristensen, MD (2) (Surgeon) 
Andreas Kappel, MD (3) (Surgeon)  
Henrik Schrøder, MD (4) (Surgeon) 
Anders Odgaard, MD (5) (Surgeon) 
Sponsor 
                      Zimmer Biomet 

 
Investigating institutions in Denmark 
 1) Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre (1) 
DK-2650 Hvidovre, Copenhagen, Denmark 
2) Dept. of Orthopaedic Surgery, Vejle Sygehus, Sygehus Lillebælt (3) 
DK-7100, Vejle, Denmark 
3) Dept. of Orthopaedic Surgery, Farsø Sygehus, Ålborg Universitetshospital (4) 
DK-9000, Aalborg, Denmark 
4) Dept. of Orthopaedic Surgery, Næstved Sygehus, (5) 
DK-4700, Næstved, Denmark 
5) Dept. of Orthopaedic Surgery, Copenhagen University Hospital Gentofte, (6) 
DK-2900, Hellerup, Denmark 
 
Institution for radiographic data analysis and data collection 
1) Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre (1) 
DK-2650 Hvidovre, Copenhagen, Denmark. 
 

 
Study Synopsis 
TITLE 
Multicenter Prospective Randomized Control Study on Persona Total Knee System vs 
NexGen Total Knee System in Total Knee Arthroplasty  
PROTOCOL NUMBER 
K.CR.I.EU.15.13 (RCT) 
STUDY DESIGN 
Multicenter, 2-arm, randomized, controlled, single-blinded post-market study 
STUDY OBJECTIVES / 
ENDPOINTS 
Primary endpoint:  
Evaluate patient reported outcome measures following primary total knee 
replacement using Persona Total Knee system compared to NexGen total Knee 
System as measured by: Oxford Knee Score (3 months, 1 and 2 years 
postoperatively) 
Secondary endpoints:  
• 
Evaluate patient reported outcome measures following primary total knee 
replacement using Persona Total Knee system compared to NexGen total Knee 
System as measured by: Oxford Knee Score -Activity & Participation 
Questionnaire (APQ) anchoring questions, EQ-5D and Forgotten Joint Score (3 
months, 1 and 2 years postoperatively). 
• 
Evaluate intra-operative and postop complications as well as long-term 
survivorship following primary total knee replacement using Persona Total Knee 
system compared to NexGen total Knee System as follows: 
- Radiolucency / osteolysis at immediate postop 3 months, 1 and 2 year 
postoperatively. 
- Adverse Events including intraoperative complications and revisions at any 
post-operative time points. 
- Survival through registries at 5,7 and 10 years postoperatively. 
INCLUSION/EXCLUSION 
CRITERIA 
Inclusion criteria: 
• 
Patients with clinical and radiological osteoarthritis of the knee set to receive 
a primary unilateral total knee replacement 
• 
>18 years of age 
• 
Participants must be able to speak and understand Danish, able to give 
informed consent and be cognitively intact, able to complete all post-
operative controls 
• 
Participants must not have severe comorbidities, ASA score ≤ 3 
• 
Patients should be clinically suitable to receive a CR implant (no severe 
deformity and/or ligament instability) 
Exclusion criteria: 
• 
Terminal illness 
• 
Revision knee replacement surgery 

 
• 
RA 
• 
Traumatic etiology 
• 
Prior surgery on the affected knee that includes osteosynthesis, ACL and/or 
PCL and/or collateral ligament surgery. Arthroscopy with menisceotomy / 
cartilage surgery / house cleaning is allowed. 
• 
Altered pain perception and / or neurologic affection due to diabetes or 
other disorders. 
• 
Patients will be excluded intraoperative if CR implant is not suitable 
SAMPLE SIZE 
314 patients 
LENGTH OF STUDY 
Start/End-date: 2016 / 2029 (18 months enrolment, 2 years postoperative visits, up 
to 10 years postoperative follow-up in the registries) 
INVESTIGATIONAL PRODUCTS 
Persona Total Knee System  
NexGen total Knee System 
• 
Only cruciate retaining (CR) components will be used in this study. 
• 
Both cemented and cementless femoral components  
• 
Both standard as well as narrow femoral components  
• 
Only cemented tibial components 
• 
Conventional polyethylene will be used for patients >65 years old and 
Vitamin-E infused poly insert may be used for patients ≤ 65 years old. 
• 
Resurfacing of patella is performed in all cases. 
SCORES/PERFORMANCE 
ASSESSMENTS 
OKS, OKS-APQ, EQ-5D, FJS, Patient satisfaction, ROM, X-rays (AP/lateral) 
STATISTICAL REPORTING 
• 
Using a two-sided t-test, 90% power and SD =10, 266 patients would be 
required. Accounting for a 15% drop-out 314 patients are planned to be 
enrolled. 
• 
Non-inferiority analysis will be performed after 216 patients, based on OKS at 
one-year post randomization; MCID is set at 4 points. 
• 
Using a one-sided t-test, 90% power and SD =10, non-inferiority margin of 4 
OKS, 216 patients would be required for the NI analysis.  
• 
The power calculation is based on reaching sufficient power when a 
comparison of the study groups is carried out.