RSA Study of Persona TKA With CR vs MC Polyethylene

NCT03494348 | Unknown FDA Device

• 1 other identifier: Persona RSA study_MT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Keywords

Radiostereometry (RSA); Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Radiostereometry (RSA)

  Measure the change in component migration over time (translation and rotation around the x-, y- and z-axis)

  First postoperative day, 3 months, 1 year, 2 years and 5 years

Secondary Outcomes (4)

• Computer Tomography (CT)

  Preoperatively and 3 months postoperatively

• Conventional radiography

  Preoperatively and 3 months postoperatively

• General health questionnaire

  Preoperatively, 1, 2 and 5 years postoperatively

• Knee specific health questionnaire

  Preoperatively, 1, 2 and 5 years postoperatively

Study Arms (2)

Cruciate Retaining Polyethylene (CR)

NO INTERVENTION

This is the standard Polyethylene articular surface

Medial Congruent Polyethylene (MC)

ACTIVE COMPARATOR

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.

Device: Medial Congruent Polyethylene (MC)

Interventions

Medial Congruent Polyethylene (MC) DEVICE

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

Also known as: MC

Medial Congruent Polyethylene (MC)

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Department of Orthopedics, Skane University Hospital, Lund University

Lund, 22185, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Gunnar Flivik, MD PhD

  Dept of Orthopedics, Skåne University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 11, 2018
• Study Start: October 1, 2017
• Primary Completion: October 30, 2020
• Study Completion: December 1, 2023
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

SE (1)