CoreHip - Post Market Clinical Follow-Up Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Degenerative Osteoarthritis; Rheumatic Arthritis; Fractures, Hip; Necrosis, Femur Head
• Intervention / Treatment: Device: CoreHip Total Hip Arthroplasty

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 Type: Observational
• Enrollment (Actual): 248

Contacts and Locations

• Study Contact: Name: Kerstin Bergmann; Phone Number: +49-7461-95-0; Email: kerstin.bergmann@aesculap.de
• Study Contact Backup: Name: Marius Selig; Phone Number: +49746195; Email: marius.selig@aesculap.de

Study Locations

• Germany
  • Salzkotten, Germany, 33154
    • St. Josefs Krankenhaus Endoprothetik Zentrum
  • Baden-Württemberg
    • Markgröningen, Baden-Württemberg, Germany, 71706
      • Ortrhopädische Klinik Markgröningen
  • Bayern
    • München, Bayern, Germany, 81369
      • Orthopädische Chirurgie München
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • MHH
• Switzerland
  • Brig, Switzerland, 3902
    • Spital Brig
  • Sursee, Switzerland, 6210
    • Luzerner Kantonsspital Sursee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

adult patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CoreHip; Clinical and Radiological Data of 300 patients of a Standard Patient Population, who are treated with CoreHip Total Hip Arthroplasty for Indications according to the Instructions for Use (IfU) with a five year follow Up	Device: CoreHip Total Hip Arthroplasty; Replacement of the Hip Joint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restoration of preoperative leg length	Comparison of preoperative and postoperative leg length	preoperative and 3 months postoperative
Restoration of preoperative offset	Comparison of preoperative and postoperative Offset angle of the femoral neck	preoperative and 3 months postoperative
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
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
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
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
Adverse Events	documentation of all product related adverse Events occuring with the Hip Prosthesis throughout the follow-up period	up to five years
Survival Rate of the Hip Prosthesis	Survival Analysis of stems in-situ throughout the follow-up period	up to five years

Collaborators and Investigators

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: Henning Windhagen, Prof. Dr. med., Orthopädische Kliniken im Annastift, Medizinische Hochschule Hannover

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2018
• Primary Completion (Actual): April 30, 2023
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: September 21, 2018
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Hip Arthroplasty; Hip Prosthesis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Fractures, Bone; Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Bone Diseases; Femoral Fractures; Hip Injuries; Osteonecrosis; Osteoarthritis; Necrosis; Hip Fractures; Rheumatic Fever; Femur Head Necrosis
• Other Study ID Numbers: AAG-O-H-1509

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No