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A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen

Key facts

Who runs it
Zimmer Biomet
Where
Denmark5 sites in 1 countryChoose a country to see its sites
Trial code
Status
Active, not recruiting
People taking part
332 people enrolled
Started
Dec 2016
Expected to end
31 Dec 2031
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Persona total knee system
  • Nexgen total knee system
Record updated
12 May 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Clinical and radiological osteoarthritis of the knee set to receive a primary unilateral total knee replacement
  • >18 years of age
  • Participants must be able to speak and understand Danish
  • Participants must be able to give informed consent and be cognitively intact
  • Participants must be able to complete all post-operative controls
  • Participants must not have severe comorbidities, American Society of Anesthesiologists (ASA) score ≤ 3
  • Clinically suitable to receive a CR implant (no severe deformity and/or ligament instability)

Who cannot take part

  • Revision knee replacement surgery
  • Prior surgery on the affected knee that includes osteosynthesis, Anterior cruciate ligament (ACL) and/or Posterior cruciate ligament (PCL) and/or collateral ligament surgery. Arthroscopy with meniscectomy / cartilage surgery / house cleaning is allowed
  • Patients will be excluded intraoperative if CR implant is not suitable
  • Terminal illness
  • Altered pain perception and / or neurologic affection due to diabetes or other disorders
  • Rheumatoid Arthritis (RA)
  • Traumatic etiology

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

A multicenter, prospective randomized controlled trial comparing the Persona knee system to the Nexgen knee system in total knee arthroplasty.

The 2 groups in the trial

  • Persona CRExisting treatment, for comparison

    Patients who received a Persona CR total knee implant

    Treatment: Persona total knee system

  • NexGen CRExisting treatment, for comparison

    Patients who received a NexGen CR total knee implant

    Treatment: Nexgen total knee system

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen Total Knee System in Total Knee Arthroplasty
Record updated
12 May 2026