Prospective, Non-Interventional, Multicenter, Post-Market Clinical Follow-up Study CoreHip®
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Aesculap AG
- Enrollment
- 248
- Locations
- 6
- Primary Endpoint
- Change of Hip Joint Function measured by Harris Hip Score over time (HHS)
Study Overview
Brief Summary
The study is designed as a prospective, non-interventional multicentre cohort study. The product under Investigation will be used in Routine clinical practice and according to the authorized Instructions for Use (IfU). Aim of this observational study is to collect clinical and radiological results of the CoreHip® endoprosthesis system in a Standard Patient Population and when used in Routine clinical practice.
Detailed Description
The CoreHip® System has a range of different stem designs to address most of the indications and anatomical conditions met in Primary THA patients within one implant and Instrument System.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient age ≥ 18 years
- •Indication for THA with a CoreHip® stem
- •Written informed consent
Exclusion Criteria
- •Pregnancy
- •Patient age < 18 years
- •Patient not able to regularly participate at the follow-up examinations
Outcomes
Primary Outcomes
Change of Hip Joint Function measured by Harris Hip Score over time (HHS)
Time Frame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
The Harris Hip Score (HHS) assesses the results of hip surgery, evaluates various hip disabilities and methods of treatment in an adult population. The HHS is a clinician-based outcome measure. The domains covered are pain (pain severity and its effect on activities and need for pain medication), function (daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance)), absence of deformity, and range of Motion (hip flexion, adduction, internal rotation, and extremity length discrepancy). There are 10 items. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
Secondary Outcomes
- Restoration of preoperative leg length(preoperative and 3 months postoperative)
- Restoration of preoperative offset(preoperative and 3 months postoperative)
- Change of Oxford Hip Score (OHS) over time(Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative)
- Survival Rate of the Hip Prosthesis(up to five years)
- Change of Quality of Life (EQ-5D-5L) over time(Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative)
- Development of Radiological results: radiolucent lines(Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative)
- Adverse Events(up to five years)
- Change of Radiological results: implant position(Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative)