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

NCT ID: NCT04164147

Last Updated: 2021-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-12-31

Brief 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

Detailed 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.

Conditions

Knee Osteoarthritis; Knee Arthritis; Joint; Arthrosis, Primary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NexGen

Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet NexGen prosthesis

Group Type: ACTIVE_COMPARATOR

Total knee replacement

Intervention Type: PROCEDURE

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

CT scan

Intervention Type: DIAGNOSTIC_TEST

CT scans of the affected knee joint before and after the surgical procedure

Biomechanics

Intervention Type: DIAGNOSTIC_TEST

Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively

one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implant

Intervention Type: DEVICE

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.

Persona MC Retained PCL

Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Retained PCL prosthesis

Group Type: ACTIVE_COMPARATOR

Total knee replacement

Intervention Type: PROCEDURE

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

CT scan

Intervention Type: DIAGNOSTIC_TEST

CT scans of the affected knee joint before and after the surgical procedure

Biomechanics

Intervention Type: DIAGNOSTIC_TEST

Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively

one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implant

Intervention Type: DEVICE

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.

Persona MC Sacrificed PCL

Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet Persona MC Sacrificed PCL prosthesis

Group Type: ACTIVE_COMPARATOR

Total knee replacement

Intervention Type: PROCEDURE

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

CT scan

Intervention Type: DIAGNOSTIC_TEST

CT scans of the affected knee joint before and after the surgical procedure

Biomechanics

Intervention Type: DIAGNOSTIC_TEST

Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively

one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implant

Intervention Type: DEVICE

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.

Interventions

Total knee replacement

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

Intervention Type: PROCEDURE

CT scan

CT scans of the affected knee joint before and after the surgical procedure

Intervention Type: DIAGNOSTIC_TEST

Biomechanics

Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Artur Stolarczyk

Head of the Department of Orthopedic and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Artur Stolarczyk, PhD

Role: STUDY_DIRECTOR

Medical University of Warsaw

Locations

Department of Othopedics and Rehabilitation, Medical University of Warsaw

Warsaw, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Bartosz Maciąg, MD

Role: CONTACT

bartosz.maciag94@gmail.com

881568144 ext. 0048

Facility Contacts

Bartosz M. Maciąg, MD

Role: primary

bmaciag@wum.edu.pl

881 568 144 ext. +48

References

Maciag BM, Kordyaczny T, Jegierski D, Lapinski M, Dorocinska M, Zarnovsky K, Maciag GJ, Adamska O, Stolarczyk A. Differences in joint line level and posterior condylar offset during total knee replacement with use of gap-balancing and measured resection techniques-matched cohort study. BMC Musculoskelet Disord. 2023 Jul 25;24(1):610. doi: 10.1186/s12891-023-06722-1.

Reference Type: DERIVED

PMID: 37491199 (View on PubMed)

Other Identifiers

WarszawMU

Identifier Type: -

Identifier Source: org_study_id