Clinical trial NCT06033625: Joint Awareness After Total Knee Replacement
Official title: Joint Awareness After Cemented or Cementless Total Knee Replacement: Does it Change?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Arthroplasty Complications
Keywords: Joint Awareness
Total Knee Replacement
Cementless
Forgotten Joint Score
Patient's Joint Perception
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with primary end stage varus osteoarthritis of the knee

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.

Detailed description: In this longitudinal case-control study, joint awareness in prosthetic reconstruction was evaluated in 150 knees (75 cemented TKR, 75 cementless TKR) of 136 patients. They were operated between 2015 and 2017 in our institution with minimum 5 years of follow up. All the patients in each group were operated by two senior surgeons that were experienced for more than 10 years in arthroplasty. To reduce selection bias, logistic regression was used to develop propensity-matched pairs based on gender, age, body mass index (BMI), preoperative coronal plane deformity, preoperative range of motion (ROM) and appropriateness for TKA indication. Demographic and clinical data including sex, age and time since surgery were collected. The subjects' joint perception and the WOMAC clinical scores were recorded and compared. Joint awareness is assessed with Forgotten Joint Score (FJS) which has 12 questions and with Patient's Joint Perception questionnaire (PJP) which is a single question with 5 possible answers, rating from the highest expected result "like a native or natural joint" to the worse possible case "a non-functional joint". Other than clinical scores, laboratory parameters, blood transfusion needs, tourniquet time, complications (septic/aseptic loosening, periprosthetic fracture, instability) and revision rates were also compared.

Eligibility criteria: Inclusion Criteria:

* primary knee osteoarthritis
* "appropriate'' TKA indication according to Modified Escobar System

Exclusion Criteria:

* secondary osteoarthritis
* previous surgery to the knee
* valgus knee
* uncontrolled diabetes

Primary outcomes:
measure: Forgotten Joint Score-12 (FJS-12)
timeFrame: 1 year after index surgery and at the end of 5th year
measure: Patient's Joint Perception questionnaire (PJP)
timeFrame: 1 year after index surgery and at the end of 5th year
Secondary outcomes:
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 1 year after index surgery and at the end of 5th year
Other outcomes:
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