Osteoarthritis, HipNCT03168750
Analysis of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component
An observational study of Osteoarthritis, Hip, run by Medacta USA at 3 sites in United States.
Trial summary
This prospective study will evaluate the hip function and quality of life of patients operated for total hip arthroplasty with Masterloc femoral stem and MPACT acetabular cup. The results of this study will establish the performance of Masterloc femoral component (Medacta International SA) and MPACT acetabular… Read more about this study
- Who is it for?
- Ages Up to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup.
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Jul 2017to 13 Nov 2024
- 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 Up to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients undergoing surgery as part of routine care.
Who may be able to join
- Primary osteoarthritis of the hip necessitating primary hip replacement,
- Suitability for straight cementless stem,
- Adult male and female under 75 years old,
- Ability to give informed consent ,
- Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up.
Who cannot join
- Off-label use of the Medacta Masterloc femoral component and MPACT acetabular component
- Post-traumatic deformity in the affected hip,
- Patient suffering from Inflammatory arthritis including rheumatoid arthritis,
- Patient suffering by congenital or developmental deformity,
- Severe osteoporosis,
- History of surgery in the affected hip,
Show all 10Show fewer
- Perioperative fracture,
- Personality disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain,
- Patients with a history of active infection
- Pregnant women or those seeking to become pregnant
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tucson Othropedic Institute
Oro Valley, Arizona, 85755
Spokane Joint Replacement Center
Spokane, Washington, 99218
Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence
West Jordan, Utah, 84088
About this study
Official title: Prospective, Multicenter Study to Assess Performance of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component in Total Hip Arthroplasty
This prospective study will evaluate the hip function and quality of life of patients operated for total hip arthroplasty with Masterloc femoral stem and MPACT acetabular cup. The results of this study will establish the performance of Masterloc femoral component (Medacta International SA) and MPACT acetabular component (Medacta International SA), and provide a general estimate of survivorship, clinical effectiveness and complications.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Femoral Component:Medacta Masterloc Stem and Medacta MPACT 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.
Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup.Device
Total hip arthroplasty (THA) is one of the most commonly performed and successful orthopaedic operations in improving a patient's quality of life. Orthopaedic surgeons are continually striving to improve all aspects of care relating to this procedure whether this is improvements in implant technology, instrument improvement, or the technique involved in performing the procedure.The results of this study will establish the performance of the femoral component and acetabular component, and provide a general estimate of survivorship, clinical effectiveness and complications.
| Study group | Role | What they receive |
|---|---|---|
| Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup | All patients enrolled will receive the Medacta Masterloc Stem and MPACT cup with Highcross PE liner. Receives: Device: Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score (HHS)
Assessment of the improvement of clinical outcomes following total hip replacement using the Harris Hip Score
Measured: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Hip Disability and Osteoarthritis Outcome Score (HOOS)
Assessment of the improvement in activity levels following total hip replacement using the Hip Disability and Osteoarthritis Outcome Score
Measured: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Oxford Hip Score (OHS)
Assessment of the improvement in the patients physical level of activity using the Oxford Hip Score
Measured: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Veterans Rand 12 (VR-12)
Assessment of the improvement in your health using the Veterans Rand 12
Measured: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
EuroQol 5 dimension (EQ-5D)
Assessment of the improvement in quality of life and joint movement using the EQ-5D
Measured: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Secondary outcomes (1)
Radiographic analysis
Radiographic analysis will include evaluation of osteolysis, radiolucent lines, bone hypertrophy, component migration, heterotopic ossification, resorption of calcar.
Measured: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start25 Jul 2017
- Primary completion13 Nov 2024
- Study completion13 Nov 2024
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medacta USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168750
- Sponsor's protocol ID
- MUSA-H-ML-001
- Status last verified
- Nov 2024
- First submitted
- 17 May 2017
- Last updated
- 21 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Study to Assess Performance of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03168750
- Acronym / sponsor ID
- MUSA-H-ML-001
- Conditions
- Osteoarthritis, Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medacta USAIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 30 May 2017 (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 prospective study will evaluate the hip function and quality of life of patients operated for total hip arthroplasty with Masterloc femoral stem and MPACT acetabular cup. The results of this study will establish the performance of Masterloc femoral component (Medacta International SA) and MPACT acetabular component (Medacta International SA), and provide a general estimate of survivorship, clinical effectiveness and complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup | – | Device: Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup.All patients enrolled will receive the Medacta Masterloc Stem and MPACT cup with Highcross PE liner. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing surgery as part of routine care.
Key inclusion criteria (5 listed)
- Primary osteoarthritis of the hip necessitating primary hip replacement,
- Suitability for straight cementless stem,
- Adult male and female under 75 years old,
- Ability to give informed consent ,
- Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up.
Key exclusion criteria (10 listed)
- Off-label use of the Medacta Masterloc femoral component and MPACT acetabular component
- Post-traumatic deformity in the affected hip,
- Patient suffering from Inflammatory arthritis including rheumatoid arthritis,
- Patient suffering by congenital or developmental deformity,
- Severe osteoporosis,
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 |
|---|---|---|
| Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup.Total hip arthroplasty (THA) is one of the most commonly performed and successful orthopaedic operations in improving a patient's quality of life. Orthopaedic surgeons are continually striving to improve all aspects of care relating to this procedure whether this is improvements in implant technology, instrument improvement, or the technique involved in performing the procedure.The results of this study will establish the performance of the femoral component and acetabular component, and provide a general estimate of survivorship, clinical effectiveness and complications. | Device | Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup |
Primary outcome
Harris Hip Score (HHS)
Time frame: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Assessment of the improvement of clinical outcomes following total hip replacement using the Harris Hip Score
Hip Disability and Osteoarthritis Outcome Score (HOOS)
Time frame: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Assessment of the improvement in activity levels following total hip replacement using the Hip Disability and Osteoarthritis Outcome Score
Oxford Hip Score (OHS)
Time frame: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Assessment of the improvement in the patients physical level of activity using the Oxford Hip Score
Veterans Rand 12 (VR-12)
Time frame: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Assessment of the improvement in your health using the Veterans Rand 12
EuroQol 5 dimension (EQ-5D)
Time frame: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Assessment of the improvement in quality of life and joint movement using the EQ-5D
1 secondary outcome
Radiographic analysis
Time frame: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
Related trials for Osteoarthritis, Hip
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip, run by Medacta USA at 3 sites in United States.
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 5 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: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.). The study lists 5 primary outcomes in all. 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 21 Nov 2024.