Concordia Hip & Knee Institute
Winnipeg, Manitoba, R2K 2M9, Canada
NCT Number: NCT06696313
The purpose of this study is to assess the migration pattern of the Insignia hip stem using radiostereometric analysis (RSA for short) and computed tomography (CT). Only patients with degenerative joint disease requiring primary total hip replacement will be asked to participate. The other purpose is to assess if there are any differences between the gold-standard RSA-measured migration and CT-RSA-measured migration. The clinical outcomes will be measured using joint function and patient satisfaction questionnaires. Approximately thirty patients will be enrolled onto the study.
This study is active but is not currently recruiting participants.
Notify Me21 year and older
All sexes
Interventional
Not applicable
Winnipeg, Manitoba, R2K 2M9, Canada
This is a single-centre, non-randomized, non-controlled trial of patients undergoing primary total hip arthroplasty using the Insignia hip stem. Patients will undergo RSA and CT-RSA imaging and analyses to identify migration of the femoral stem with respect to the adjuvant bone during the first 2 post-operative years.
The primary outcome of this study is to determine if femoral stem stability is achieved between 6-12 month and 12-24 month post-operative intervals.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Up to 2 years post-operative
Quantify migration of the Insignia stem using RSA and CT-RSA
Time frame: Up to 2 years post-operative
Comparison of RSA and CT-RSA using the standard deviation of the mean component migration calculated from examinations.
Time frame: Up to 2 years post-operative
Quantify early migration of the Trident acetabular cup using RSA
Time frame: Up to 2 years post-operative
The Oxford Hip Score (OHS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OHS measures pain and general activities of daily living
Time frame: Up to 2 years post-operative
The EuroQol 5D 5L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
Time frame: Up to 2 years post-operative
Evaluate and compare the change from preoperative to 2 years in patient reported satisfaction as measured using the visual analogue scale (VAS) from 0 (Unsatified) - 100 (Completely Satisfied).
Canadian Radiostereometric Analysis Network
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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