Degenerative OsteoarthritisNCT03685110
CoreHip - Post Market Clinical Follow-Up Study
An observational study of Degenerative Osteoarthritis and Rheumatic Arthritis, run by Aesculap AG at 6 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Osteoarthritis, Rheumatic Arthritis, Fractures, Hip
- What is being tested?
- CoreHip Total Hip Arthroplasty
- Type of treatment
- Medical device
- How many people
- 248 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 16 Oct 2018to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Who may be able to join
- Patient age ≥ 18 years
- Indication for THA with a CoreHip® stem
- Written informed consent
Who cannot join
- Pregnancy
- Patient age < 18 years
- Patient not able to regularly participate at the follow-up examinations
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany4 sites
MHH
Hanover, Lower Saxony, 30625
Ortrhopädische Klinik Markgröningen
Markgröningen, Baden-Wurttemberg, 71706
Orthopädische Chirurgie München
München, Bavaria, 81369
St. Josefs Krankenhaus Endoprothetik Zentrum
Salzkotten, 33154
Switzerland2 sites
Spital Brig
Brig, 3902
Luzerner Kantonsspital Sursee
Sursee, 6210
About this study
Official title: 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.
Read the 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.
- Being tested
- CoreHip Total Hip Arthroplasty
- Keywords
- Hip Arthroplasty, Hip Prosthesis
- Medical subject headings
- Joint Diseases, Rheumatic Fever, Hip Fractures, Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoreHip Total Hip ArthroplastyDevice
Replacement of the Hip Joint
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: CoreHip Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
Secondary outcomes (8)
Restoration of preoperative leg length
Comparison of preoperative and postoperative leg length
Measured: preoperative and 3 months postoperative
Restoration of preoperative offset
Comparison of preoperative and postoperative Offset angle of the femoral neck
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: up to five years
Survival Rate of the Hip Prosthesis
Survival Analysis of stems in-situ throughout the follow-up period
Measured: up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start16 Oct 2018
- Primary completion30 Apr 2023
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henning Windhagen, Prof. Dr. med., Principal investigator, Orthopädische Kliniken im Annastift, Medizinische Hochschule Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685110
- Sponsor's protocol ID
- AAG-O-H-1509
- Status last verified
- Mar 2026
- First submitted
- 21 Sep 2018
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-Interventional, Multicenter, Post-Market Clinical Follow-up Study CoreHip®
- ClinicalTrials.gov ID
- NCT03685110
- Acronym / sponsor ID
- AAG-O-H-1509
- Keywords
- Hip Arthroplasty, Hip Prosthesis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoreHip | – | Device: CoreHip Total Hip ArthroplastyClinical 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (3 listed)
- Patient age ≥ 18 years
- Indication for THA with a CoreHip® stem
- Written informed consent
Key exclusion criteria (3 listed)
- Pregnancy
- Patient age < 18 years
- Patient not able to regularly participate at the follow-up examinations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoreHip Total Hip ArthroplastyReplacement of the Hip Joint | Device | CoreHip |
Primary outcome
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).
8 secondary outcomes
Restoration of preoperative leg length
Time frame: preoperative and 3 months postoperative
Restoration of preoperative offset
Time frame: preoperative and 3 months postoperative
Change of Oxford Hip Score (OHS) over time
Time frame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
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
Change of Radiological results: implant position
Time frame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
Development of Radiological results: radiolucent lines
Time frame: Preoperative, 3 months postoperative, approx. 12-24 months postoperative and approx. 5 years postoperative
Adverse Events
Time frame: up to five years
Survival Rate of the Hip Prosthesis
Time frame: up to five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henning Windhagen, Prof. Dr. med. principal investigator
Orthopädische Kliniken im Annastift, Medizinische Hochschule Hannover
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Osteoarthritis and Rheumatic Arthritis, run by Aesculap AG at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.