Post Market Clinical Follow-Up (PMCF) Study to Evaluate the Performance and Safety of the Cemented TrendHip® Stem in a Prospective Follow-up Study
Overview
- Phase
- Not Applicable
- Intervention
- Total Hip Arthroplasty
- Conditions
- Coxarthrosis; Primary
- Sponsor
- Aesculap AG
- Enrollment
- 119
- Locations
- 6
- Primary Endpoint
- Change of functional outcome over five year follow-up period (modified Harris Hip Score)
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
This Post Market Clinical Follow-Up (PMCF) study to evaluate the performance and safety of the cemented TrendHip® stem in a prospective follow-up study with patients who underwent a hip arthroplasty with the investigational product (representative of usual clinical practice), at two follow-up examinations
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion: Inclusion criteria
- •Patient older than 18 years.
- •Patient who undergo / underwent a hip arthroplasty with cemented TrendHip® femoral stem according to the indications for implantation specified in the Instructions for Use.
- •Patient not opposing participation in the study.
Exclusion Criteria
- •Patient with shortened life expectancy.
- •The patient is unable to commit to the planned follow-up period.
Arms & Interventions
TrendHip®
Intervention: Total Hip Arthroplasty
Outcomes
Primary Outcomes
Change of functional outcome over five year follow-up period (modified Harris Hip Score)
Time Frame: preoperative (as available) and at two examinations during Follow-Up (1 year postop, 5 years postop)
The modified Harris Hip Score (mHHS) as patient-reported outcome measure and evaluated one-year and five-years postoperatively. The mHHS is a validated and disease-specific instrument commonly used to assess outcomes in total hip arthroplasty. The domains covered are pain, function (gait), and functional activities.
Secondary Outcomes
- Patient satisfaction with surgery result(at two examinations during Follow-Up (1 year postop, 5 years postop))
- Radiological Outcome: Migration of the stem in mm(at two examinations during Follow-Up (1 year postop, 5 years postop))
- Pain Assessment(at two examinations during Follow-Up (1 year postop, 5 years postop))
- Survival rate (Kaplan-Meier)(at two examinations during Follow-Up (1 year postop, 5 years postop))
- Radiological Outcome: Evaluation of bony osseointegration or conspicuous features of the stem(at two examinations during Follow-Up (1 year postop, 5 years postop))
- Radiological Outcome: Heterotopic Ossification(at two examinations during Follow-Up (1 year postop, 5 years postop))