Osteoarthritis, HipNCT04688593
Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up
An observational study of Osteoarthritis, Hip and Hip Osteoarthritis, run by Waldemar Link GmbH & Co. KG at 2 sites in 2 countries.
Trial summary
The implantation of artificial hip joints is one of the most frequently performed surgeries. Normally, patients are very satisfied with the results. The MobileLink hip prosthesis system is a CE marked medical device. This means the the safety and performance of the prosthesis ist approved. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip, Hip Osteoarthritis, Prosthesis Survival
- What is being tested?
- MobileLink
- Type of treatment
- Medical device
- How many people
- 520 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 4 May 2021to Jan 2036
- 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
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Implantation of a MobileLink acetabular cup system and a femoral stem manufactured by Waldemar Link
- Age ≥ 18 years
- Fully signed patient informed cons
Who cannot join
- Revisions
- Body Mass Index (BMI) ≥ 40 kg/m²
- Patient who is foreseeable not able to understand the study and the study-related circumstances
- Patients who is foreseeable non-compliant to the treatment and the follow-ups
- Pregnant or breast-feeding women
- Prisoner
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United Kingdom1 site, 1 recruiting
- Recruiting
NHS FIFE Victoria Hospital
Kirkcaldy
Muhammad Adeel Akhtar
About this study
The implantation of artificial hip joints is one of the most frequently performed surgeries. Normally, patients are very satisfied with the results.
The MobileLink hip prosthesis system is a CE marked medical device. This means the the safety and performance of the prosthesis ist approved. Aim of the study is to collect clinical data about the outcome of the MobileLink hip prosthesis system under routine condition and to determine the satisfaction of the patients.
- Being tested
- MobileLink
- Keywords
- MobileLink
- Medical subject headings
- Osteoarthritis, Hip, Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobileLinkDevice
Patients who receive a MobileLink hip prosthesis system will be followed-up for 10 years.
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint,
calculated with Kaplan-Meier method.
Measured: 10-years
Secondary outcomes (19)
Revision rates of the complete MobileLink acetabular cup system with revision for any reason except peri-prosthetic infections as the endpoint
Measured: 3 months, 1 year, 3, 5, 7 and 10 years
Revision rates of the MobileLink acetabular cup system shell(s) with revision for any reason as the endpoint
Measured: 3 months, 1 year, 3, 5, 7 and 10 years
Revision rates of the MobileLink acetabular cup system inserts (Ceramic, XLINKed, E-Dur) with revision for any reason as the endpoint
Measured: 3 months, 1 year, 3, 5, 7 and 10 years
Revision rates of the combined LINK hip stem(s) with revision for any reason as the endpoint
Measured: 3 months, 1 year, 3, 5, 7 and 10 years
Change of baseline hip functionality
measured by the Harris Hip Score (HHS) (maximum 100 points, minimum 0 points, a higher score indicates a better outcome)
Measured: pre-operatively and at the 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Change of baseline hip functionality
measured by the Hip disability and osteoarthritis outcome score (HOOS), (maximum 100 points, minimum 0 points, a higher score indicates a better outcome)
Measured: pre-operatively and at the 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Rate of complications and re-operations of the hip joint
Measured: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Rate of failed osteointegrated cups
radiological assessment
Measured: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Rate of failed osteointegrated stems
radiological assessment
Measured: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Change of postoperative cup position
radiological assessment
Measured: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Change of postoperative stem position
radiological assessment
Measured: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Occurence of heterotopic ossifications
radiological assessment, classified according to Brooker
Measured: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Type and rate of complications with the used instruments related to usability and sterilization
Measured: intraoperatively
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
calculated with Kaplan-Meier method.
Measured: 3 month
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
calculated with Kaplan-Meier method.
Measured: 1 year
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
calculated with Kaplan-Meier method.
Measured: 3 year
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
calculated with Kaplan-Meier method.
Measured: 5 year
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
calculated with Kaplan-Meier method.
Measured: 7 year
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
calculated with Kaplan-Meier method.
Measured: 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start4 May 2021
- Primary completionJan 2036 (estimated)
- Study completionJan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Waldemar Link GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688593
- Sponsor's protocol ID
- HP15
- Status last verified
- Jan 2024
- First submitted
- 16 Dec 2020
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Functional Outcome of the MobileLink Acetabular Cup System in the Short-, Mid-, and Longterm Follow-up
- ClinicalTrials.gov ID
- NCT04688593
- Acronym / sponsor ID
- HP15
- Keywords
- MobileLink
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Waldemar Link GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 4 May 2021 (actual)
- Primary completion
- Jan 2036 (estimated)
- Study completion
- Jan 2036 (estimated)
- First posted
- 30 Dec 2020 (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 implantation of artificial hip joints is one of the most frequently performed surgeries. Normally, patients are very satisfied with the results.
The MobileLink hip prosthesis system is a CE marked medical device. This means the the safety and performance of the prosthesis ist approved. Aim of the study is to collect clinical data about the outcome of the MobileLink hip prosthesis system under routine condition and to determine the satisfaction of the patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (3 listed)
- Implantation of a MobileLink acetabular cup system and a femoral stem manufactured by Waldemar Link
- Age ≥ 18 years
- Fully signed patient informed cons
Key exclusion criteria (6 listed)
- Revisions
- Body Mass Index (BMI) ≥ 40 kg/m²
- Patient who is foreseeable not able to understand the study and the study-related circumstances
- Patients who is foreseeable non-compliant to the treatment and the follow-ups
- Pregnant or breast-feeding women
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 |
|---|---|---|
| MobileLinkPatients who receive a MobileLink hip prosthesis system will be followed-up for 10 years. | Device | – |
Primary outcome
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint,
Time frame: 10-years
calculated with Kaplan-Meier method.
19 secondary outcomes
Revision rates of the complete MobileLink acetabular cup system with revision for any reason except peri-prosthetic infections as the endpoint
Time frame: 3 months, 1 year, 3, 5, 7 and 10 years
Revision rates of the MobileLink acetabular cup system shell(s) with revision for any reason as the endpoint
Time frame: 3 months, 1 year, 3, 5, 7 and 10 years
Revision rates of the MobileLink acetabular cup system inserts (Ceramic, XLINKed, E-Dur) with revision for any reason as the endpoint
Time frame: 3 months, 1 year, 3, 5, 7 and 10 years
Revision rates of the combined LINK hip stem(s) with revision for any reason as the endpoint
Time frame: 3 months, 1 year, 3, 5, 7 and 10 years
Change of baseline hip functionality
Time frame: pre-operatively and at the 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Change of baseline hip functionality
Time frame: pre-operatively and at the 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Rate of complications and re-operations of the hip joint
Time frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Rate of failed osteointegrated cups
Time frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Rate of failed osteointegrated stems
Time frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Change of postoperative cup position
Time frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Change of postoperative stem position
Time frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Occurence of heterotopic ossifications
Time frame: 3 months, 1 year, 3, 5, 7 and 10 year follow-up
Type and rate of complications with the used instruments related to usability and sterilization
Time frame: intraoperatively
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
Time frame: 3 month
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
Time frame: 1 year
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
Time frame: 3 year
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
Time frame: 5 year
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
Time frame: 7 year
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint
Time frame: 10 year
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 25 Jan 2024.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip and Hip Osteoarthritis, run by Waldemar Link GmbH & Co. KG at 2 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 6 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: looking for participants now, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, United Kingdom. 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?
Contact Lisa Skottke, PhD (+494053995673, l.skottke@link-ortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate of the complete MobileLink hip prosthesis system with revision for any reason as the endpoint, (time frame: 10-years). 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 25 Jan 2024.