CoreHip - Post Market Clinical Follow-Up Study

Degenerative Osteoarthritis Clinical Trial

Official title:

Prospective, Non-Interventional, Multicenter, Post-Market Clinical Follow-up Study CoreHip®

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03685110
• Other study ID #: AAG-O-H-1509
• Status: Active, not recruiting
• Start date: October 16, 2018
• Est. completion date: December 2028

Study information

• Verified date: February 2024
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 248
• Est. completion date: December 2028
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Osteoarthritis
• Femur Head Necrosis
• Fractures, Hip
• Hip Fractures
• Necrosis
• Necrosis, Femur Head
• Osteoarthritis
• Rheumatic Arthritis
• Rheumatic Fever

Intervention

Device:
• CoreHip Total Hip Arthroplasty
Replacement of the Hip Joint

Locations

Country	Name	City	State
Germany	MHH	Hannover	Niedersachsen
Germany	Ortrhopädische Klinik Markgröningen	Markgröningen	Baden-Württemberg
Germany	Orthopädische Chirurgie München	München	Bayern
Germany	St. Josefs Krankenhaus Endoprothetik Zentrum	Salzkotten
Switzerland	Spital Brig	Brig
Switzerland	Luzerner Kantonsspital Sursee	Sursee

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Hip Joint Function measured by Harris Hip Score over time (HHS)	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).	Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
Secondary	Restoration of preoperative leg length	Comparison of preoperative and postoperative leg length	preoperative and 3 months postoperative
Secondary	Restoration of preoperative offset	Comparison of preoperative and postoperative Offset angle of the femoral neck	preoperative and 3 months postoperative
Secondary	Change of Oxford Hip Score (OHS) over time	A patient-reported outcome instrument which contains 12 questions on activities of daily living that assess function and residual pain in patients undergoing total hip replacement (THR) surgery. The score has a maximum of 48 points (best possible outcome), each question has five answers, ranging from 4 Points (best possible) to 0 Points (worst possible).	Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
Secondary	Change of Quality of Life (EQ-5D-5L) over time	EuroQol five-dimension scale. A standardised instrument created by the EuroQol Group as a measure of health outcome. EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take one of five Levels reflecting severity (no problems, slight problems, moderate problems, severe problems and extreme Problems). Each answer results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
Secondary	Change of Radiological results: implant position	Changes in implant Position throughout the follow-up period	Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
Secondary	Development of Radiological results: radiolucent lines	Development of radiolucent lines ("Gruen" zones) in AP and lateral x-rays throughout the follow-up period	Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
Secondary	Adverse Events	documentation of all product related adverse Events occuring with the Hip Prosthesis throughout the follow-up period	up to five years
Secondary	Survival Rate of the Hip Prosthesis	Survival Analysis of stems in-situ throughout the follow-up period	up to five years