Osteoarthritis, HipNCT06870123
MINIMA Stem With DELTA TT or DELTA ST-C Study
A study testing TT cup and ST-C cup in people with Osteoarthritis, Hip, run by Limacorporate S.p.a at 1 site in Slovakia.
Trial summary
This study is aimed to provide a clinical and radiographic evaluation of 120 suitable subjects who underwent a total hip arthroplasty with MINIMA stem coupled with Delta TT or Delta ST-C cup. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- TT cup and ST-C cup
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSlovakia
- Study dates
- 15 Feb 2022to 15 Feb 2029
- Phase
- Interventional
- 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
Who may be able to join
- Both genders
- Any race
- A diagnosis in the target hip of one or more of the following: a) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis; b) rheumatoid arthritis; c) post-traumatic arthritis; d) fractures of femoral neck;
- patien willingness to partecipate and signature of informed consent form
Who cannot join
- local or systemic infection
- septicaemia
- persistent acute or chronic osteomyelitis
- confirmed nerve or muscle lesion compromising hip joint function
- vascular or nerve disease affecting the concerned limb
- poor bone stock (for example due to osteoporosis) compromising the stability of the implant
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- metabolic disorders which may impair fixation and stability of the implant
- any concomitant disease and dependence that might affect the implanted prosthsis
- metal hypersensitivity to implant materials
- required revision of previous standard femoral stem
- women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remail on an acceptable method of birth control throughout the entire study period
- life expectancy less than 5 years
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
The Orthopedic Clinic University Hospital Martin
Martin, 036 59
About this study
Official title: A Prospective Randomized Clinical Study Evaluating the Outcomes of MINIMA Stem With DELTA TT or DELTA ST-C Cup After Total Hip Arthroplasty
This study is aimed to provide a clinical and radiographic evaluation of 120 suitable subjects who underwent a total hip arthroplasty with MINIMA stem coupled with Delta TT or Delta ST-C cup.
Read the detailed description
This is a post-market, interventional, prospective, randomized, not comparative, open label study designed to reflect real life clinical practice as closely as possible.
- Conditions
- Osteoarthritis, Hip
- Being tested
- TT cup and ST-C cup
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TT cup and ST-C cupDevice
Patients are allocated in 2 different group (one with ST-C Cup and another one with TT Cup)
| Study group | Role | What they receive |
|---|---|---|
| Minima Stem with ST-c Cup | Other | Minima Stem with ST-c Cup Receives: Device: TT cup and ST-C cup |
| Minima Stem with TT Cup | Other | Minima Stem with TT Cup Receives: Device: TT cup and ST-C cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score (HHS)
Functional changes in Harris Hip Score (HHS) from preoperative (baseline) to 3 years after surgery.
The Harris Hip Score is composed of ten items covering foru domains: pain, fuction, absence of deformity and range of motion. The maximum score is 100 points. Pain domain contributes 44 points, function 47, Range of Motion 5 and absence of deformity 4 points. Results can be interpreted as follows: less than 60 points corresponds to a failed result, from 60 to 69 to a poor result, from 70 to 79 points to a fair outcome, from 80 to 90 to a good result ad from 90 to 100 to an excellent outcome. Overall, the outcome is considered satisfactory for values over 80 points.
Measured: Pre-operative, 3 months, 6 months, 1 year and 3 years
Secondary outcomes (6)
Harris Hip Score (HHS)
Functional changes in Harris Hip Score (HHS) from preoperative (baseline) to 5 years after surgery.
The Harris Hip Score is composed of ten items covering foru domains: pain, fuction, absence of deformity and range of motion. The maximum score is 100 points. Pain domain contributes 44 points, function 47, Range of Motion 5 and absence of deformity 4 points. Results can be interpreted as follows: less than 60 points corresponds to a failed result, from 60 to 69 to a poor result, from 70 to 79 points to a fair outcome, from 80 to 90 to a good result ad from 90 to 100 to an excellent outcome. Overall, the outcome is considered satisfactory for values over 80 points.
Measured: 5 years
Implant stability
Radiographic implant evaluation and stability assessment at 6 months, 1 year, 3 years, 5 years after surgery
Measured: 6 months, 1 year, 3 years, 5 years after surgery
Oxford Hip Score (OHS)
Functional changes in Oxford Hip Score (OHS) from preoperative (baseline) to 5 years after surgery.
The Oxford Hip Score is composed of two domains (pain and function) with six items or questions in each that are scored as follows: each question can be scored from 0 to 4, with 4 being the best outcome, producing overall scores running from 0 to 48, with 48 being the best outcome. The calculation of the total score is based on the above-mentioned scoring system, with a score reported as excellent for more than 41 points, good from 34 to 41, fair from 27 to 33 and poor for less than 27 points.
Measured: Pre-operative, 3 months, 6 months, 1 year, 3 years, and 5 years
Forgotten Joint Score (FJS)
Changes in Forgotten Joint Score (FJS) from 3 months (baseline) to 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery.
The Forgotten Joint Score is a 12 item questionnaire that integrates variables such as pain, stiffness, function on activities of daily living, ptients' expectations and activity levels and finally psychosocial factors. It consist of 12 questions scored using a 5-point Likert response format (never-almost never-seldom-sometimes-mostly) with raw scores transformed onto a 0-100 point scale. High scores indicate good outcome, that is, a high degree of "forgetting" the joint.
Measured: 3 months (baseline) to 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery
Survival Rate
Survival rate expressed with Kaplan-Meier estimator at 5 years after surgery
Measured: 5 years
Safety assessment
Incidence, type, and severity of all the Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) occurred at each follow-up.
Measured: Intra operative, 3 months, 6 months, 1 year, 3 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start15 Feb 2022
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2029 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870123
- Sponsor's protocol ID
- H-41
- Status last verified
- Aug 2026
- First submitted
- 5 Mar 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Study Evaluating the Outcomes of MINIMA Stem With DELTA TT or DELTA ST-C Cup After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06870123
- Acronym / sponsor ID
- H-41
- Conditions
- Osteoarthritis, Hip
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Feb 2029 (estimated)
- First posted
- 11 Mar 2025 (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.
This study is aimed to provide a clinical and radiographic evaluation of 120 suitable subjects who underwent a total hip arthroplasty with MINIMA stem coupled with Delta TT or Delta ST-C cup.
Detailed description
This is a post-market, interventional, prospective, randomized, not comparative, open label study designed to reflect real life clinical practice as closely as possible.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minima Stem with ST-c Cup | Other | Device: TT cup and ST-C cupMinima Stem with ST-c Cup |
| Minima Stem with TT Cup | Other | Device: TT cup and ST-C cupMinima Stem with TT Cup |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both genders
- Any race
- A diagnosis in the target hip of one or more of the following: a) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis; b) rheumatoid arthritis; c) post-traumatic arthritis; d) fractures of femoral neck;
- patien willingness to partecipate and signature of informed consent form
Key exclusion criteria (12 listed)
- local or systemic infection
- septicaemia
- persistent acute or chronic osteomyelitis
- confirmed nerve or muscle lesion compromising hip joint function
- vascular or nerve disease affecting the concerned limb
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 |
|---|---|---|
| TT cup and ST-C cupPatients are allocated in 2 different group (one with ST-C Cup and another one with TT Cup) | Device | Minima Stem with ST-c Cup, Minima Stem with TT Cup |
Primary outcome
Harris Hip Score (HHS)
Time frame: Pre-operative, 3 months, 6 months, 1 year and 3 years
Functional changes in Harris Hip Score (HHS) from preoperative (baseline) to 3 years after surgery. The Harris Hip Score is composed of ten items covering foru domains: pain, fuction, absence of deformity and range of motion. The maximum score is 100 points. Pain domain contributes 44 points, function 47, Range of Motion 5 and absence of deformity 4 points. Results can be interpreted as follows: less than 60 points corresponds to a failed result, from 60 to 69 to a poor result, from 70 to 79 points to a fair outcome, from 80 to 90 to a good result ad from 90 to 100 to an excellent outcome. Overall, the outcome is considered satisfactory for values over 80 points.
6 secondary outcomes
Harris Hip Score (HHS)
Time frame: 5 years
Implant stability
Time frame: 6 months, 1 year, 3 years, 5 years after surgery
Oxford Hip Score (OHS)
Time frame: Pre-operative, 3 months, 6 months, 1 year, 3 years, and 5 years
Forgotten Joint Score (FJS)
Time frame: 3 months (baseline) to 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery
Survival Rate
Time frame: 5 years
Safety assessment
Time frame: Intra operative, 3 months, 6 months, 1 year, 3 years, 5 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 12 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TT cup and ST-C cup in people with Osteoarthritis, Hip, run by Limacorporate S.p.a at 1 site in Slovakia.
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 12 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 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. 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?
Harris Hip Score (HHS) (time frame: Pre-operative, 3 months, 6 months, 1 year and 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 12 Aug 2026.