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Active, Not Recruiting

NCT Number: NCT03685110

CoreHip - Post Market Clinical Follow-Up Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Degenerative Osteoarthritis Arthritis Bacterial Infections Bacterial Infections and Mycoses Bone Diseases Connective Tissue Diseases Femoral Fractures Femur Head Necrosis Fractures, Bone Fractures, Hip Gram-Positive Bacterial Infections Hip Fractures Hip Injuries Infections Joint Diseases Leg Injuries Musculoskeletal Diseases Necrosis Necrosis, Femur Head Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Arthritis Rheumatic Diseases Rheumatic Fever Skin and Connective Tissue Diseases Streptococcal Infections Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ortrhopädische Klinik Markgröningen, Markgröningen, Baden-Wurttemberg, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CoreHip Total Hip Arthroplasty

Device

Replacement of the Hip Joint

Primary outcomes

  1. 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

  1. Restoration of preoperative leg length

    Time frame: preoperative and 3 months postoperative

    Comparison of preoperative and postoperative leg length

  2. Restoration of preoperative offset

    Time frame: preoperative and 3 months postoperative

    Comparison of preoperative and postoperative Offset angle of the femoral neck

  3. Change of Oxford Hip Score (OHS) over time

    Time frame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative

    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).

  4. Change of Quality of Life (EQ-5D-5L) over time

    Time frame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative

    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.

  5. Change of Radiological results: implant position

    Time frame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative

    Changes in implant Position throughout the follow-up period

  6. Development of Radiological results: radiolucent lines

    Time frame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative

    Development of radiolucent lines ("Gruen" zones) in AP and lateral x-rays throughout the follow-up period

  7. Adverse Events

    Time frame: up to five years

    documentation of all product related adverse Events occuring with the Hip Prosthesis throughout the follow-up period

  8. Survival Rate of the Hip Prosthesis

    Time frame: up to five years

    Survival Analysis of stems in-situ throughout the follow-up period

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2028
First posted
Sep 26, 2018
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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