Persona MC Retained PCL vs. Persona Posterior-stabilized vs. NexGen PS

Knee Osteoarthritis Clinical Trial

— Persona TKA  

Official title:

Comparison of the Persona Medial Congruent Retained Posterior-Cruciate Ligament vs. Persona Posterior-stabilized vs. NexGen Posterior-Stabilized Total Knee Arthroplasty a Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04164147
• Other study ID #: WarszawMU
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Medical University of Warsaw
• Contact: Bartosz Maciag, MD
• Phone: 881568144
• Email: bartosz.maciag94[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study compares and evaluates differences in movement analysis, patient-reported outcome and radiological assesment between patients undergoing total knee arthroplasty with use of either Zimmer Biomet NexGen and Zimmer Biomet PERSONA

Description:

Osteoarthritis causes the joints to become painful and stiff. Osteoarthritis of the knee is a common condition that is expected to be a lot more frequent in the next two decades. As a consequence, an increase of total knee replacement surgery is predicted. Total knee replacement surgery is offered when knee pain and stiffness caused by osteoarthritis can no longer be managed and these symptoms significantly impact on an individual's normal activities of daily living. Most total knee replacements are successful but up to 34% of all patients have poor functional outcomes following surgery. This leaves affected people at a greater risk of reduced physical activity and thus impacts longer-term general health. Poor outcomes are therefore of importance to patients and have a considerable financial and service-provision impact on National Health Service (NHS) care. While patient-related characteristics and their relationship to patient outcomes have been identified, few studies have been undertaken to determine how kinematic outcomes (how the prosthetic knee moves) are related to functional outcome and patient satisfaction. The kinematic outcome of a total knee replacement is hypothesised to relate to both the structural design (shape) of the implant and the surgical procedure itself. To date, no studies have investigated the kinematic outcomes of different total knee replacement prosthesis designs through a range of typical activities of everyday mobility (functional outcomes). Whilst it is known that long term success of total knee replacement depends largely upon correct alignment of the prosthesis components during surgery, no studies have looked at the anatomical alignments of the osteoarthritic knee prior to undergoing surgery (using Computerised Tomography (CT) scanning). The aim of the study is to examine relationships between movement analysis (kinematic and functional outcomes), patient reported outcome measures (PROMS) and CT measurement, both pre- and post-operatively, between two knee prosthesis including one that has been designed to improve functional outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Listed for a primary total knee replacement (TKR) at the Orthopaedic and Rehabilitation Department Medical University of Warsaw

2. Indication for the TKR is primary osteoarthritis of the knee joint involving one or more compartments

3. Aged 18 or over

4. Patient willing to provide full informed consent to the trial

Exclusion Criteria:

1. Listed for a single-stage bilateral TKR procedure

2. Severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure

3. Fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur

4. Clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater

5. Any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient's safety

6. Inflammatory arthritis

7. Previous septic arthritis in the affected knee joint

8. Previous surgery to the collateral ligaments of the affected knee

9. A contralateral total knee replacement that has been implanted less than one year from the date of consultation

10. A contralateral total knee replacement that is severely painful

11. Patients on warfarin or novel oral anticoagulants (NOACs)

12. Will not be resident in the catchment area for at least 6 months post-surgery

13. Undertaking the surgery as a private patient

14. Patients who, in the opinion of the clinical staff, do not have capacity to consent

15. Patients who are pregnant

16. Unable to understand written and spoken Polish

Related Conditions & MeSH terms

• Joint Diseases
• Joint; Arthrosis, Primary
• Knee Arthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Total knee replacement
Participant will undergo total knee replacement performed via anterior parapatellar approach with either Posterior Cruciate Ligament sacrificing or retaining implant

Diagnostic Test:
• CT scan
CT scans of the affected knee joint before and after the surgical procedure
• Biomechanics
Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively

Device:
• one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implant
Participant are randomly allocated to receive one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and the NexGen PS total knee implant for treatment of end-stage knee osteoarthritis.

Locations

Country	Name	City	State
Poland	Department of Othopedics and Rehabilitation, Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in patients reported outcome measures - Oxford Knee Score (OKS)	To explore differences between outcome in patients treated with use of with Nexgen and Persona prosthesis. Results range from 0 to 48, with higher scores corresponding to better outcomes.	baseline (preoperatively) and 6-months postoperatively
Secondary	Changes in patients reported outcome measures - Oxford Knee Score (OKS)	To explore differences between outcome in patients treated with use of with Nexgen and Persona prosthesis. Results range from 0 to 48, with higher scores corresponding to better outcomes.	1 week and 6-8 weeks post-operatively
Secondary	Changes in patients reported outcomes - Oxford Knee Score Activity & Participation Questionnaire (OKS_APQ)	To explore differences in higher levels of activity and social participation	1 week, 6-8 weeks and 6 months post- operatively
Secondary	Changes in patients reported outcomes - EuroQol (EQ- 5D-5L)	To explore differences in quality of life	1 week, 6-8 weeks and 6 months post- operatively
Secondary	Changes in patients reported outcomes - Forgotten Joint Score (FJS)	To explore differences in patient's ability to forget about a joint as a result of successful treatment. Results range from 0 to 100, with higher scores corresponding to better outcomes.	6-8 weeks and 6 months post-operatively
Secondary	Changes in patients reported outcomes - UCLA (University of California) score	To explore differences in patient's physical activity. Results range from 0 to 10, with higher scores corresponding to better outcomes.	6-8 weeks and 6 months post-operatively
Secondary	Changes in knee range of motion	To explore differences in range of motion (flexion and extension)	preoperatively, 6-8 weeks and 6 months post-operatively
Secondary	Changes in pain medication	To asses evolution of post-operative knee pain	1 week, 6-8 weeks and 6 months post-operatively
Secondary	arthroplasty related complications	To count and asses all complications that may occur during surgery and in postoperative period	1 week, 6-8 weeks and 6 months post-operatively
Secondary	arthroplasty revision surgeries	To count and asses the reason of all revision surgeries that may occur during postoperative period	1 week, 6-8 weeks and 6 months post-operatively
Secondary	walking abilities	To asses "up and go" time	6-8 weeks and 6 months post-operatively
Secondary	Length of hospital stay	To measure number of days counting from surgery to the discharge	from baseline to discharge from hospital ranging averagely from 1 up to 7 days postoperatively
Secondary	Biomechanical 3D miotion and emg walking outcomes	Overground walking is measured using 3D Motion analysis and electromyography (EMG)	at baseline, 6-8 weeks and 6 months post-operatively
Secondary	Radiological outcome on CT scans	Rotational alignment of the total knee component is assessed by measuring the femoral antetorsion, Alignment of the total knee component is assessed by measuring the tibial tubercle-trochlear groove distance (TT-TG)	at baseline preoperatively and 6-months postoperatively
Secondary	6- minute walking abilities	to asses pace and model of 6-minute walk	6-8 weeks and 6 months post-operatively
Secondary	Biomechanical stair climbing outcomes	Stair climbing and descending is measured using 3D Motion analysis and EMG	at baseline, 6-8 weeks and 6 months post-operatively
Secondary	Biomechanical static balance outcomes	Static balance is measured using a force plate	at baseline, 6-8 weeks and 6 months post-operatively
Secondary	Biomechanical dynamic balance outcomes	Dynamic balance is measured using a force plate and the modified Star Excursion Balance Test (mSEBT)	at baseline, 6-8 weeks and 6 months post-operatively
Secondary	Leg muscle strength outcomes	Leg muscle strength measured using maximal voluntary isometric contraction (MVIC) test of the hamstring and quadriceps muscles on both limbs.	at baseline, 6-8 weeks and 6 months post-operatively