NCT03563131

Brief Summary

The purpose of this study: In a prospective randomized study with 2 years of follow-up we want to compare the migration of the uncemented trabecular metal (TM) versus the cemented tibial and femoral components of the new Persona® total knee arthroplasty (TKA) assessed by model based radiostereometric analysis (MB-RSA). Also, we want to compare the adaptive bone remodeling induced by the uncemented TM versus the cemented tibial and femoral components of the new Persona® TKA assessed by dual energy-X-ray (DEXA). Data generated for both above mentioned, will be also compared with historical RSA and DEXA data for the NexGen TKA using TM tibia modular and monoblock.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Aug 2018Dec 2026

First Submitted

Initial submission to the registry

June 8, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2019

Completed
7.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

1.2 years

First QC Date

June 8, 2018

Last Update Submit

June 24, 2024

Conditions

Osteo Arthritis Knee

Keywords

OsteoarthritisKneeArthroplasties

Outcome Measures

Primary Outcomes (1)

  • Migration

    The differences between the cemented and uncemented implants are evaluated by measurements of migration of the stem assesed by Radiosteriometric analysis (RSA), measuring the migration by the MB-RSA Commercial software.

    2 years

Secondary Outcomes (1)

  • Adaptive bone remodelling

    2 years

Other Outcomes (2)

  • Knee function assessed with Knee Society Score

    2 years

  • Knee function assessed with Oxford Knee Score

    2 years

Study Arms (2)

Uncemented Persona® total knee arthroplasty

ACTIVE COMPARATOR

Uncemented TM Zimmer Persona® TKA. It is a relatively new implant that is now in routine clinical use. Implants are approved by FDA and CE marked. Patella will be resurfaced with the cemented Zimmer 3-Peg All Polyethylene Patella.

Device: Persona® total knee arthroplasty

Cemented Persona® total knee arthroplasty

ACTIVE COMPARATOR

Cemented Zimmer Persona® TKA. It is a relatively new implant that is now in routine clinical use. Implants are approved by FDA and CE marked. Patella will be resurfaced with the cemented Zimmer 3-Peg All Polyethylene Patella.

Device: Persona® total knee arthroplasty

Interventions

Persona® total knee arthroplastyDEVICE

Insertion of the cemented or uncemented Persona® total knee arthroplasty

Cemented Persona® total knee arthroplastyUncemented Persona® total knee arthroplasty

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Osteoarthrosis of the knee with indication for a TKA.
  • Age between 40 and 70 years.

You may not qualify if:

  • If a standard cruciate retaining implants cannot be used due to e.g. severe malalignment/deformity or instability.
  • Diseases affecting the bone metabolism (severe osteoporosis, Pagets disease, hyperparathyreoidism etc.).
  • Patients estimated not to be able to understand the "Information to patients" papers or do not want to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Michael M Petersen, Professor

    Rigshospitalet, Denmark

    STUDY DIRECTOR

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
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor,Research Fellow

Study Record Dates

First Submitted

June 8, 2018

First Posted

June 20, 2018

Study Start

August 1, 2018

Primary Completion

October 10, 2019

Study Completion (Estimated)

December 31, 2026

Last Updated

June 25, 2024

Record last verified: 2024-06

Locations

DK(1)