Patients Requiring Hip ReplacementNCT02126345
MASTER SL Clinical Study
An observational study of Patients Requiring Hip Replacement, run by Limacorporate S.p.a at 4 sites in United Kingdom.
Trial summary
The purpose of this study is: to generate data to evaluate Orthopaedic Data Evaluation Panel (ODEP) rating to support existing short-term clinical results and CE documentation; to assess the clinical performance of the MASTER SL femoral stem and the DELTA TT acetabular cup under standard conditions of use; to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Requiring Hip Replacement
- What is being tested?
- MASTER SL femoral stem and DELTA TT acetabular cup
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- May 2014to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients Requiring Hip Replacement
Who may be able to join
- Male and female ≥18 years;
- Radiologically confirmed diagnosis of primary osteoarthritis (OA) of the hip and suitable for primary total hip replacement;
- Life expectancy of >10 years;
- Voluntary written Informed Consent obtained.
Who cannot join
- Prospect for recovery to independent mobility compromised by known coexistent, medical problems;
- Requiring revision hip replacement;
- Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip joint;
- Previous organ transplant;
- Previous hip replacement (resurfacing or THR) on the contra-lateral side within the last 6 months;
- Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an Oxford Hip score <18 points;
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- Body mass index (kg/m2) exceeds 40;
- Active or suspected infection;
- Known sensitivity to device materials;
- Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Royal Bournemouth Hospital NHS Foundation Trust
Bournemouth
University Hospital Llandough Cardiff and Vale University Health Board
Cardiff
The Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry
University Hospital Southampton NHS Foundation Trust
Southampton
About this study
Official title: A Prospective, Observational, Multi-centre, Cohort Study of the MASTER SL Femoral Stem and the DELTA TT Acetabular Cup in Patients With Degenerative Disease of the Hip
The purpose of this study is:
- to generate data to evaluate Orthopaedic Data Evaluation Panel (ODEP) rating to support existing short-term clinical results and CE documentation;
- to assess the clinical performance of the MASTER SL femoral stem and the DELTA TT acetabular cup under standard conditions of use;
- to determine any adverse events and assess whether they constitute risks when weighed against the intended performance of the device.
- Conditions
- Patients Requiring Hip Replacement
- Being tested
- MASTER SL femoral stem and DELTA TT acetabular cup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MASTER SL femoral stem and DELTA TT acetabular cupDevice
| Study group | Role | What they receive |
|---|---|---|
| MASTER SL | Not described Receives: Device: MASTER SL femoral stem and DELTA TT acetabular cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of failure
Measured: 3 years
Secondary outcomes (1)
Clinical progression measured with HHS score, OHS score, Non-Arthritic Hip Score, EQ-5D-5L
Measured: from baseline to all time-points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2021 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Requiring Hip ReplacementStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Middleton, MD, Principal investigator, Royal Bournemouth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126345
- Sponsor's protocol ID
- H-14
- Status last verified
- Aug 2021
- First submitted
- 24 Apr 2014
- Last updated
- 1 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Multi-centre, Cohort Study of the MASTER SL Femoral Stem and the DELTA TT Acetabular Cup in Patients With Degenerative Disease of the Hip
- ClinicalTrials.gov ID
- NCT02126345
- Acronym / sponsor ID
- H-14
- Conditions
- Patients Requiring Hip Replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- May 2014 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 30 Apr 2014 (estimated)
- 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 purpose of this study is:
- to generate data to evaluate Orthopaedic Data Evaluation Panel (ODEP) rating to support existing short-term clinical results and CE documentation;
- to assess the clinical performance of the MASTER SL femoral stem and the DELTA TT acetabular cup under standard conditions of use;
- to determine any adverse events and assess whether they constitute risks when weighed against the intended performance of the device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MASTER SL | – | Device: MASTER SL femoral stem and DELTA TT acetabular cup |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients Requiring Hip Replacement
Key inclusion criteria (4 listed)
- Male and female ≥18 years;
- Radiologically confirmed diagnosis of primary osteoarthritis (OA) of the hip and suitable for primary total hip replacement;
- Life expectancy of >10 years;
- Voluntary written Informed Consent obtained.
Key exclusion criteria (10 listed)
- Prospect for recovery to independent mobility compromised by known coexistent, medical problems;
- Requiring revision hip replacement;
- Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip joint;
- Previous organ transplant;
- Previous hip replacement (resurfacing or THR) on the contra-lateral side within the last 6 months;
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 |
|---|---|---|
| MASTER SL femoral stem and DELTA TT acetabular cup | Device | MASTER SL |
Primary outcome
Rate of failure
Time frame: 3 years
1 secondary outcome
Clinical progression measured with HHS score, OHS score, Non-Arthritic Hip Score, EQ-5D-5L
Time frame: from baseline to all time-points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
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.
Robert Middleton, MD principal investigator
Royal Bournemouth Hospital NHS Foundation Trust
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Requiring Hip Replacement, run by Limacorporate S.p.a at 4 sites in United Kingdom.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in 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?
Results are not available in the source record.
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?
Rate of failure (time frame: 3 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 1 Sep 2021.