Clinical Trials Directory

Trials / Completed

CompletedNCT06033625

Joint Awareness After Total Knee Replacement

Joint Awareness After Cemented or Cementless Total Knee Replacement: Does it Change?

Status
Completed
Phase
Study type
Observational
Enrollment
150 (actual)
Sponsor
Saglik Bilimleri Universitesi · Academic / Other
Sex
All
Age
65 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURECEMENTLESS TOTAL KNEE REPLACEMENTCEMENTLESS CRUCIATE RETAINING BICOMPARTMENTAL TOTAL KNEE REPLACEMENT

Timeline

Start date
2015-01-01
Primary completion
2017-01-01
Completion
2019-01-01
First posted
2023-09-13
Last updated
2023-09-21

Source: ClinicalTrials.gov record NCT06033625. Inclusion in this directory is not an endorsement.