Comparison of an Old Versus a New Total Knee Replacement
A Randomized Controlled Clinical and RSA Study of 2 Total Knee Replacement Designs: A Comparison of Nexgen CR and Persona CR
1 other identifier
interventional
185
1 country
1
Brief Summary
A randomized controlled clinical and RSA study, comparing 2 knee implants:
- Helse Bergen HF, Kysthospitalet i Hagavik (KIH)
- Helse Førde HF, Lærdal sykehus
- Helse Bergen HF, Haukeland universitetssykehus (HUS) 1-3 surgeons in each hospital will perform the operations. There will be 80 patients in the 2 groups; a total of 160 study patients will be included. 30 in each group will be included for RSA. Radiostereometric analysis (RSA) will be used to measure migration and subsidence of components in addition to regular radiographs. 3 different knee scoring systems will be used to evaluate satisfaction and function. An activity monitor will be used to assess real-life physical behavior and walking speed to assess objectively measured mobility. Data from the Norwegian Arthroplasty Register will be used to investigate the risk of revision.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Longer than P75 for not_applicable
1 active site
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 Start
First participant enrolled
May 18, 2017
CompletedFirst Submitted
Initial submission to the registry
May 24, 2018
CompletedFirst Posted
Study publicly available on registry
June 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 5, 2029
September 18, 2025
September 1, 2025
12.1 years
May 24, 2018
September 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FJS12
Forgotten joint score 12
10 year follow up
Secondary Outcomes (6)
KSS
10 years
KOOS
10 years
EQ5D
10 years
Revision risk
10 years
Walking speed
10 years
- +1 more secondary outcomes
Other Outcomes (2)
Radiographs
10 years
RSA
10 years
Study Arms (2)
RSA radiostereometric analysis
OTHER30 patients in each Group Persona or Nexgen will receive tantalus beads to achieve RSA analysis comparing micromevements in radiographs.
Clinical comparison
OTHERClinical comarison using different patient reported outcome measures and objective measures (ActivePAL, walking speed)
Interventions
Tantalum beads will be inserted in polyethylene Component and in bone to assess micromotion of Components in radiographs
Eligibility Criteria
You may qualify if:
- Patients under the age of 80
- Both gender
- Primary osteoarthritis
- BMI ≤ 35
You may not qualify if:
- Patient over the age of 80
- Other diagnoses than primary osteoarthritis
- BMI \>35
- ASA 4 patients (American Society of Anesthesiologists)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helse-Bergen HFlead
Study Sites (1)
Helse Bergen, Kysthospitalet i Hagavik
Hagavik, 5217, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ove Furnes, Professor
Helse Bergen, Norwegian Arthroplasty Register
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of knee surgery
Study Record Dates
First Submitted
May 24, 2018
First Posted
June 7, 2018
Study Start
May 18, 2017
Primary Completion (Estimated)
July 5, 2029
Study Completion (Estimated)
July 5, 2029
Last Updated
September 18, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share