RSA Study of Persona TKA With CR vs MC Polyethylene

NCT ID: NCT03494348

Last Updated: 2022-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to evaluate, over a 2 year period, the migration pattern, function and the possibility of anatomical reconstruction of a relatively new total knee arthroplasty (TKA) concept, the Persona. Sixty patients will be randomized into 2 groups of 30 patients each, with one group receiving the Persona TKA with a conventional Cruciate Retaining (CR) polyethylene articular surface and the other group with a newly developed Medial Congruent (MC) articular surface. Patients will be followed up with Radiostereometry (RSA), conventional radiography, outcome questionnaires, clinical evaluation and Computer Tomography (CT). The migration pattern of the components will be evaluated as well as the degree of anatomical reconstruction and clinical result.

We plan also to do a 5 year follow-up of the patients with RSA and PROMS.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cruciate Retaining Polyethylene (CR)

This is the standard Polyethylene articular surface

Group Type NO_INTERVENTION

No interventions assigned to this group

Medial Congruent Polyethylene (MC)

The intervention here will be the MC articular surface. This is the new Polyethylene articular surface with a more congruent medial side and a more flat lateral side which should better resemble natural anatomy.

Group Type ACTIVE_COMPARATOR

Medial Congruent Polyethylene (MC)

Intervention Type DEVICE

One group receives the conventional CR surface and the other the new MC articular surface

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Medial Congruent Polyethylene (MC)

One group receives the conventional CR surface and the other the new MC articular surface

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Osteoarthritis of the knee necessitating knee replacement
* ASA I-III
* BMI 18 - 35

Exclusion Criteria

* Joint sepsis in history
* immunosuppresive drugs last 5 years
* Rheumatoid arthritis
* Severe osteoporosis or other metabolic bone diseases
* Neuromuscular diseases
* Personal disorders suspected of limiting rehab and completion of the trial period
* Previous osteotomy of affected limb
* Intra-articular knee fracture of affected limb
* Peroperative fracture
* Severe deformity of affected joint in need of augmentation or excessive release
* Obvious need for more constrained knee than CR
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zimmer Biomet

INDUSTRY

Sponsor Role collaborator

Region Skane

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gunnar Flivik, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Dept of Orthopedics, Skåne University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Orthopedics, Skane University Hospital, Lund University

Lund, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Persona RSA study_MT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Persona Total Knee Arthroplasty Outcomes Study
NCT02255383 ACTIVE_NOT_RECRUITING NA
Persona Partial Knee Clinical Outcomes Study
NCT03034811 ACTIVE_NOT_RECRUITING NA
Persona Versus NexGen
NCT02269254 COMPLETED NA
Zimmer POLAR Persona - TKA (EMEA Study)
NCT02337244 ACTIVE_NOT_RECRUITING
Persona MC vs PS RCT With ROSA
NCT05391828 RECRUITING NA
Persona Cohort Nordic Multicenter Study
NCT03495232 ACTIVE_NOT_RECRUITING