OsteoarthritisNCT01285843
Periprosthetic Bone Mineral Density After Total Hip Arthroplasty Performed Through a Minimally Invasive Anterior Approach (AMIS) With Either an AMIStem or a Quadra Femoral Component
A study testing Anterior Minimally Invasive Approach (AMIS) in people with Osteoarthritis and Arthritis, run by Medacta International SA at 1 site in Germany.
Trial summary
This is a monocentric, prospective, randomized clinical survey to verify if the periprosthetic remodelling brought about either the AMIStem or the Quadra femoral component is equivalent. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Arthritis, Avascular Necrosis
- What is being tested?
- Anterior Minimally Invasive Approach (AMIS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
- Patients presenting with disease that meets the indications for use for Medacta implants defined by this study (on-label use (enclosure 2)).
- Patients must be willing to comply with the pre and post-operative evaluation schedule.
- Patients with only one lower limb arthroplasty
Who cannot join
- Patient with metabolic bone diseases, use of steroids or other drugs affecting bone metabolism
- Patients with osteoporosis (pre-op T-score < -2,5)
- Patients with significant comorbidities
- Patients with both hip and knee arthroplasty
- Patients with restricted mobility
- Patient with severe hip contracture
- Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Periprosthetic Bone Mineral Density After Total Hip Arthroplasty Performed Through a Minimally Invasive Anterior Approach (AMIS) With Either an AMIStem or a Quadra Femoral Component.
This is a monocentric, prospective, randomized clinical survey to verify if the periprosthetic remodelling brought about either the AMIStem or the Quadra femoral component is equivalent.
- Conditions
- Osteoarthritis, Arthritis, Avascular Necrosis, Fracture of the Femoral Neck or Head, Congenital Hip Dysplasia
- Being tested
- Anterior Minimally Invasive Approach (AMIS)
- Medical subject headings
- Osteoarthritis, Arthritis, Osteonecrosis, Hip Dislocation, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Minimally Invasive Approach (AMIS)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Quadra Group | Active comparator | Not described Receives: Procedure: Anterior Minimally Invasive Approach (AMIS) |
| AMIStem Group | Active comparator | Not described Receives: Procedure: Anterior Minimally Invasive Approach (AMIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Periprosthetic Bone Mineral Density (BMD), at 1y Postoperative, in Patients That Have Undergone a Total Hip Arthroplasty (THA) Via the Direct Anterior Approach Receiving Either a Quadra or AMIStem Femoral Component.
Measured: 0-12 months
Secondary outcomes (3)
Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score
The items in the Harris hip score (HHS) include an analysis of the operated hip according to pain, function, mobility and stability, and an analysis of deformities, in a scale form 0 point (the worst condition) to 100 points (the best condition). The Harris Hip Score will be used to assess the subjective and objective improvement in the patient. The usefulness of the score has been designed to estimate clinical outcomes after THA and demonstrated high reliability and validity.
The HHS values at each time points, 6 weeks, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative.
Measured: 6 weeks, 6 months, 1 year
Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score.
The HAAS was designed to detect subtle variations in functional ability after lower limb arthroplasty, in a scale from 0 (minimum, the worst condition) to 18 points (maximum, the best condition) The HAAS values at each time points, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative.
Measured: 6 months, 1 year
Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.
Stability and fixation of both, femoral and acetabular component will be assessed counted number of events of stem subsidence, femoral and cup loosening, cup migration and presence of radiolucencies occurred during the study at 6 months and 1 year time points.
Measured: 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startSep 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Nolde, Dr. Med., Principal investigator, DGOOC; BVO; BVASK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285843
- Sponsor's protocol ID
- P01.004.14
- Status last verified
- Sep 2025
- First submitted
- 26 Jan 2011
- Last updated
- 9 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periprosthetic Bone Mineral Density After Total Hip Arthroplasty Performed Through a Minimally Invasive Anterior Approach (AMIS) With Either an AMIStem or a Quadra Femoral Component.
- ClinicalTrials.gov ID
- NCT01285843
- Acronym / sponsor ID
- P01.004.14
- Conditions
- Osteoarthritis, Arthritis, Avascular Necrosis, Fracture of the Femoral Neck or Head, Congenital Hip Dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 28 Jan 2011 (estimated)
- Results
- Posted 15 Sep 2014
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 monocentric, prospective, randomized clinical survey to verify if the periprosthetic remodelling brought about either the AMIStem or the Quadra femoral component is equivalent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadra Group | Active comparator | Procedure: Anterior Minimally Invasive Approach (AMIS) |
| AMIStem Group | Active comparator | Procedure: Anterior Minimally Invasive Approach (AMIS) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
- Patients presenting with disease that meets the indications for use for Medacta implants defined by this study (on-label use (enclosure 2)).
- Patients must be willing to comply with the pre and post-operative evaluation schedule.
- Patients with only one lower limb arthroplasty
Key exclusion criteria (7 listed)
- Patient with metabolic bone diseases, use of steroids or other drugs affecting bone metabolism
- Patients with osteoporosis (pre-op T-score < -2,5)
- Patients with significant comorbidities
- Patients with both hip and knee arthroplasty
- Patients with restricted mobility
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 |
|---|---|---|
| Anterior Minimally Invasive Approach (AMIS) | Procedure or surgery | AMIStem Group, Quadra Group |
Primary outcome
Compare Periprosthetic Bone Mineral Density (BMD), at 1y Postoperative, in Patients That Have Undergone a Total Hip Arthroplasty (THA) Via the Direct Anterior Approach Receiving Either a Quadra or AMIStem Femoral Component.
Time frame: 0-12 months
3 secondary outcomes
Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score
Time frame: 6 weeks, 6 months, 1 year
Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score.
Time frame: 6 months, 1 year
Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.
Time frame: 6 months, 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Martin Nolde, Dr. Med. principal investigator
DGOOC; BVO; BVASK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Minimally Invasive Approach (AMIS) in people with Osteoarthritis and Arthritis, run by Medacta International SA at 1 site in Germany.
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 7 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: finished, as of the sponsor's last update on 9 Oct 2025. 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 Germany. 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?
Yes. Results are posted in the registry (first posted 15 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Compare Periprosthetic Bone Mineral Density (BMD), at 1y Postoperative, in Patients That Have Undergone a Total Hip Arthroplasty (THA) Via the Direct Anterior Approach Receiving Either a Quadra or AMIStem Femoral Component. (time frame: 0-12 months). 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 9 Oct 2025.