Joint Awareness After Total Knee Replacement
Joint Awareness After Cemented or Cementless Total Knee Replacement: Does it Change?
1 other identifier
observational
150
0 countries
N/A
Brief Summary
Total knee replacement (TKR) is accepted as treatment of choice for end stage gonarthrosis. It is performed cemented or cementless and although cemented implants were shown to decrease bone density more than cementless fixations there is no evidence-based difference between them in the literature. As far as the investigators are concerned, the effect of cementation on patients' joint perception has never been studied so far.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
Started Jan 2015
Longer than P75 for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
September 5, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedSeptember 21, 2023
September 1, 2023
2 years
September 5, 2023
September 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Forgotten Joint Score-12 (FJS-12)
a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment and uses a 5-point Likert response format (0, never; 1, almost; 2, seldom; 3,sometimes; and 4, mostly) with high scores indicate good outcome, which means a high degree of "forgetting" the joint
1 year after index surgery and at the end of 5th year
Patient's Joint Perception questionnaire (PJP)
The PJP is a single question with 5 possible answers, rating from the highest expected result "like a native or natural joint" to the worsening gradually as Artificial joint with no restriction, Artificial joint with minimal restriction, Artificial joint with major restriction and "a non-functional joint"
1 year after index surgery and at the end of 5th year
Secondary Outcomes (1)
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
1 year after index surgery and at the end of 5th year
Study Arms (2)
Cd-TKR
Bicompartmental cemented cruciate retaining Total knee replacement
Cs-TKR
Bicompartmental cementless cruciate retaining Total knee replacement
Interventions
CEMENTLESS CRUCIATE RETAINING BICOMPARTMENTAL TOTAL KNEE REPLACEMENT
Eligibility Criteria
Patients with primary end stage varus osteoarthritis of the knee
You may qualify if:
- primary knee osteoarthritis
- "appropriate'' TKA indication according to Modified Escobar System
You may not qualify if:
- secondary osteoarthritis
- previous surgery to the knee
- valgus knee
- uncontrolled diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical professor
Study Record Dates
First Submitted
September 5, 2023
First Posted
September 13, 2023
Study Start
January 1, 2015
Primary Completion
January 1, 2017
Study Completion
January 1, 2019
Last Updated
September 21, 2023
Record last verified: 2023-09