ArthrosisNCT05460715
The Medacta Quadra-P Anteverted Study
An observational study of Arthrosis and Traumatic Arthritis, run by Medacta International SA at 1 site in Italy.
Trial summary
This is a Post-Marketing Surveillance of Quadra-P anteverted stem prosthesis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthrosis, Traumatic Arthritis, Rheumatoid Polyarthritis
- What is being tested?
- Quadra P anteverted
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jul 2021to Jul 2032
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The aim of the study is to monitor the clinical performance and survival of the Quadra-P antevert stem when used according to its indications. Since patients are not subjected to additional risks or procedures compared to standard practice, the total number of patients was defined on the basis of the surgeon's potential and observational studies of the same type already published in the literature. For the anatomical-functional subgroup, a sample size was defined to verify 10% speed increases between pre- and postoperative. Considering α = 5% and Power = 90%, 30 patients will be required.
Who may be able to join
- Subjects suffering from primary hip arthrosis, post-traumatic arthrosis, dysplasia or avascular necrosis of the femoral head, rheumatoid arthritis
- Adult subjects between 18 and 75 years of age on the date of surgery
- Subjects eligible for primary total hip arthroplasty surgery for whom the anterior Quadra-P femoral component will be implanted according to the indications for use of the implant
- Subjects who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to surgery.
- For the anatomical-functional subgroup:
- Adult subjects aged between 18 and 65 years at the date of surgery who have agreed to undergo the gait analysis study.
Who cannot join
- Subjects with acute or chronic infection
- Subjects with a femoral neck fracture
- Subjects with mental conditions that impair their ability to consent to the study, to complete required questionnaires or to complete follow-up visits
- Subjects with severe deformities, at the discretion of the surgeon
- Subjects with metabolic disorders that may involve bone metabolism for which an uncemented implant would be contraindicated
- Subjects with muscular atrophy or neuromuscular diseases
Show all 9Show fewer
- Subjects allergic to the materials used during surgery
- Subjects unable or unwilling to provide consent for participation in the study
- Any other condition not mentioned in the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Multicentre Study to Evaluate the Long-term Performance of Anteverted Femoral Stems in Total Hip Arthroplasty
This is a Post-Marketing Surveillance of Quadra-P anteverted stem prosthesis.
Read the detailed description
The primary objective of this study is to evaluate the 10-year survival of the anteverted Quadra-P stem in patients operated for primary total hip arthroplasty, according to the inclusion criteria.
Secondary objectives:
- To assess clinical performance by Harris Hip score collected during preoperative and postoperative visits at 3 months, 1, 2, 5, 7 and 10 years.
- Assess radiological performance by standard radiographic examination performed preoperatively, postoperatively before discharge and during postoperative visits at 3 months, 1, 2, 5, 7 and 10 years.
- Assessing the patient's perception of the prosthetic joint by means of FJS questionnaire collected during the preoperative visit and postoperative visits at 3 months and at 1, 2, 5, 7 and 10 years after surgery.
- Assessment of functional recovery by gait analysis study
- Collect the rate of complications throughout the course of the study
- Conditions
- Arthrosis, Traumatic Arthritis, Rheumatoid Polyarthritis, Congenital Hip Dysplasia, Avascular Necrosis of the Femoral Head
- Being tested
- Quadra P anteverted
- Keywords
- total hip arthroplasty, Quadra P anteverted, Medacta
- Medical subject headings
- Osteoarthritis, Hip Dislocation, Congenital, Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadra P antevertedDevice
- Assess clinical performance by Harris Hip score collected during preoperative and postoperative visits at 3 months, 1, 2, 5, 7 and 10 years.
- Assess radiological performance by standard radiographic examination performed before surgery, after surgery before discharge and during postoperative visits at 3 months, 1, 2, 5, 7 and 10 years.
- Assessing the patient's perception of the prosthetic joint by means of FJS questionnaire collected during the preoperative visit and postoperative visits at 3 months and at 1, 2, 5, 7 and 10 years after surgery.
- Assessment of functional recovery by gait analysis study
- Collect the rate of complications throughout the course of the study
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the 10-year survival of the anteverted Quadra-P stem
% survival rate
Measured: 10 years
Secondary outcomes (5)
Assess clinical performance
Harris Hip score (HHS) (0 minimum-100 maximum)
Measured: at 3 months, 1, 2, 5, 7 and 10 years.
Assess radiological performance
Assess radiological performance by standard radiographic examination performed before surgery, after surgery before discharge and during postoperative visits
Measured: at pre-op, 3 months, 1, 2, 5, 7 and 10 years.
Assessing the patient's perception of the prosthetic joint
Forgotten Joint Score (FJS) (0 minimum-100 maximum)
Measured: at 3 months and at 1, 2, 5, 7 and 10 years after surgery.
Assessment of functional recovery
Assessment of functional recovery by gait analysis study
Measured: at pre-op, 3 months and at 1 year after surgery.
Collect the rate of complications
Collect the rate of complications throughout the course of the study
Measured: at pre-op, immediate post-op, 3 months, 1, 2, 5, 7 and 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start30 Jul 2021
- Primary completionJul 2032 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthrosisStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460715
- Sponsor's protocol ID
- P01.001.20
- Status last verified
- Sep 2026
- First submitted
- 12 Jul 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentre Study to Evaluate the Long-term Performance of Anteverted Femoral Stems in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05460715
- Acronym / sponsor ID
- P01.001.20
- Conditions
- Arthrosis, Traumatic Arthritis, Rheumatoid Polyarthritis, Congenital Hip Dysplasia, Avascular Necrosis of the Femoral Head
- Keywords
- total hip arthroplasty, Quadra P anteverted, Medacta
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- Jul 2032 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 15 Jul 2022 (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 is a Post-Marketing Surveillance of Quadra-P anteverted stem prosthesis.
Detailed description
The primary objective of this study is to evaluate the 10-year survival of the anteverted Quadra-P stem in patients operated for primary total hip arthroplasty, according to the inclusion criteria.
Secondary objectives:
- To assess clinical performance by Harris Hip score collected during preoperative and postoperative visits at 3 months, 1, 2, 5, 7 and 10 years.
- Assess radiological performance by standard radiographic examination performed preoperatively, postoperatively before discharge and during postoperative visits at 3 months, 1, 2, 5, 7 and 10 years.
- Assessing the patient's perception of the prosthetic joint by means of FJS questionnaire collected during the preoperative visit and postoperative visits at 3 months and at 1, 2, 5, 7 and 10 years after surgery.
- Assessment of functional recovery by gait analysis study
- Collect the rate of complications throughout the course of the study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The aim of the study is to monitor the clinical performance and survival of the Quadra-P antevert stem when used according to its indications. Since patients are not subjected to additional risks or procedures compared to standard practice, the total number of patients was defined on the basis of the surgeon's potential and observational studies of the same type already published in the literature. For the anatomical-functional subgroup, a sample size was defined to verify 10% speed increases between pre- and postoperative. Considering α = 5% and Power = 90%, 30 patients will be required.
Key inclusion criteria (6 listed)
- Subjects suffering from primary hip arthrosis, post-traumatic arthrosis, dysplasia or avascular necrosis of the femoral head, rheumatoid arthritis
- Adult subjects between 18 and 75 years of age on the date of surgery
- Subjects eligible for primary total hip arthroplasty surgery for whom the anterior Quadra-P femoral component will be implanted according to the indications for use of the implant
- Subjects who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to surgery.
- Adult subjects aged between 18 and 65 years at the date of surgery who have agreed to undergo the gait analysis study.
Key exclusion criteria (9 listed)
- Subjects with acute or chronic infection
- Subjects with a femoral neck fracture
- Subjects with mental conditions that impair their ability to consent to the study, to complete required questionnaires or to complete follow-up visits
- Subjects with severe deformities, at the discretion of the surgeon
- Subjects with metabolic disorders that may involve bone metabolism for which an uncemented implant would be contraindicated
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 |
|---|---|---|
| Quadra P anteverted* Assess clinical performance by Harris Hip score collected during preoperative and postoperative visits at 3 months, 1, 2, 5, 7 and 10 years. * Assess radiological performance by standard radiographic examination performed before surgery, after surgery before discharge and during postoperative visits at 3 months, 1, 2, 5, 7 and 10 years. * Assessing the patient's perception of the prosthetic joint by means of FJS questionnaire collected during the preoperative visit and postoperative visits at 3 months and at 1, 2, 5, 7 and 10 years after surgery. * Assessment of functional recovery by gait analysis study * Collect the rate of complications throughout the course of the study | Device | – |
Primary outcome
Evaluate the 10-year survival of the anteverted Quadra-P stem
Time frame: 10 years
% survival rate
5 secondary outcomes
Assess clinical performance
Time frame: at 3 months, 1, 2, 5, 7 and 10 years.
Assess radiological performance
Time frame: at pre-op, 3 months, 1, 2, 5, 7 and 10 years.
Assessing the patient's perception of the prosthetic joint
Time frame: at 3 months and at 1, 2, 5, 7 and 10 years after surgery.
Assessment of functional recovery
Time frame: at pre-op, 3 months and at 1 year after surgery.
Collect the rate of complications
Time frame: at pre-op, immediate post-op, 3 months, 1, 2, 5, 7 and 10 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 13 Oct 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.
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?
An observational study of Arthrosis and Traumatic Arthritis, run by Medacta International SA at 1 site in Italy.
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 6 inclusion and 9 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 13 Oct 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 Italy. 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?
Evaluate the 10-year survival of the anteverted Quadra-P stem (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 13 Oct 2026.