NCT03685110

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
2 countries

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Oct 2018Dec 2028

First Submitted

Initial submission to the registry

September 21, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

October 16, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Expected
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

4.5 years

First QC Date

September 21, 2018

Last Update Submit

March 26, 2026

Conditions

Degenerative OsteoarthritisRheumatic ArthritisFractures, HipNecrosis, Femur Head

Keywords

Hip ArthroplastyHip Prosthesis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

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

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

  • Change of Radiological results: implant position

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

  • +3 more secondary outcomes

Study Arms (1)

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

Interventions

CoreHip Total Hip ArthroplastyDEVICE

Replacement of the Hip Joint

CoreHip

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients

You may qualify if:

  • Patient age ≥ 18 years
  • Indication for THA with a CoreHip® stem
  • Written informed consent

You may not qualify if:

  • Pregnancy
  • Patient age \< 18 years
  • Patient not able to regularly participate at the follow-up examinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ortrhopädische Klinik Markgröningen

Markgröningen, Baden-Wurttemberg, 71706, Germany

Location

Orthopädische Chirurgie München

München, Bavaria, 81369, Germany

Location

MHH

Hanover, Lower Saxony, 30625, Germany

Location

St. Josefs Krankenhaus Endoprothetik Zentrum

Salzkotten, 33154, Germany

Location

Spital Brig

Brig, 3902, Switzerland

Location

Luzerner Kantonsspital Sursee

Sursee, 6210, Switzerland

Location

MeSH Terms

Conditions

Joint DiseasesRheumatic FeverHip FracturesFemur Head Necrosis

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsArthritisRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesOsteonecrosisBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Henning Windhagen, Prof. Dr. med.

    Orthopädische Kliniken im Annastift, Medizinische Hochschule Hannover

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2018

First Posted

September 26, 2018

Study Start

October 16, 2018

Primary Completion

April 30, 2023

Study Completion (Estimated)

December 1, 2028

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

DE(4)CH(2)