Hip ArthritisNCT03897387
Post Market, Retrospective Study to Evaluate Patients Implanted With Medacta Versafit Cup DM ™️ 2 Years Post-op
An observational study of Hip Arthritis, run by Medacta USA at 3 sites in United States.
Trial summary
This is a post-market, retrospective with one prospective visit, multi- center study, designed to assess the clinical outcomes, surgical details including Anterior or Posterior surgical approach, and collect all complication data of Medacta Versafit Cup DM used for primary or revision total hip arthroplasty at minimum… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Arthritis
- How many people
- 316 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2017to 30 Mar 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Up to a total of 528 qualified patients who have undergone primary or revision Total Hip Arthroplasty (THA) will be enrolled.
Who may be able to join
- Subjects age 18 years and above at the time of consent
- Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol. Written informed consent must be obtained prior to any study procedure. 3 Patients must be willing to comply with the prospective visit schedule.
- 4. Patient underwent a primary or revision total hip replacement for any etiology (osteoarthritis, avascular necrosis, inflammatory arthritis, post- traumatic arthritis, hip fracture, failed prior procedures, etc.). 5. Patients must have received a Medacta Versafit Cup DM component 6. Patient must have adequate pre-operative and post-operative radiographs 7. Patients must be at minimum 2 year (24 months) post-treatment 8. The operation was performed by the investigator.
Who cannot join
- History of alcoholism
- Currently on chemotherapy or radiation therapy
- Habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than hip pain
- History of a metabolic disorder such as Gout affecting the skeletal system other than osteoarthritis or osteoporosis
- History of chronic pain issues for reasons other than hip pain
- Women that are pregnant
- Patients who underwent Total Hip Arthroplasty (THA) using standard polyethylene
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Texas Orthopedics
Austin, Texas, 78759
Illinois Bone and Joint Institute
Libertyville, Illinois, 60048
Peak Orthopedics
Lone Tree, Colorado, 80124
About this study
Official title: A Post-market, Multi-center, Retrospective Study to Identify Clinical Outcomes and Complications Data From Patients Implanted With the Medacta Versafit Cup DM Prosthesis Who Are at Least Two Years Post Surgery
This is a post-market, retrospective with one prospective visit, multi- center study, designed to assess the clinical outcomes, surgical details including Anterior or Posterior surgical approach, and collect all complication data of Medacta Versafit Cup DM used for primary or revision total hip arthroplasty at minimum two year post- operatively.
- Conditions
- Hip Arthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Dislocation rate of Medacta Versafit Cup DM
Determine radiographic analysis of component position in millimeters
Measured: Minimum 2 years post surgery
Implant position fixation and wear
Determine by radiographic analysis by measuring Radio Lucent lines in millimeters
Measured: Minimum 2 years post surgery
Limb length
Determined by radiographic analysis by measuring in millimeters
Measured: Minimum 2 years post surgery
Patient Satisfaction and outcome score
Determined by the Hip Disability and Osteoarthritis Outcome Score (HOOS) likert scale score
Measured: Minimum 2 years post surgery
Secondary outcomes (9)
Patient questionnaire Forgotten Joint Score (FJS)
Assessment of awareness of the artificial joint in every day life using the FJS
Measured: Minimum 2 years post surgery
Patient questionnaire Harris Hip Score (HHS)
Assessment of the improvement of clinical outcomes following total hip replacement using the Harris Hip Score
Measured: Minimum 2 years post surgery
Patient questionnaire Likert Scale Score
Assessment of patient satisfaction using the Likert Scale
Measured: Minimum 2 years post surgery
Gait analysis
Assessment of patient limp, use of assistive device
Measured: Minimum 2 years post surgery
Range of Motion
Assessment of contracture
Measured: Minimum 2 years post surgery
Implant survivorship
Determine by radiographic analysis of bone fracture, implant fracture
Measured: Minimum 2 years post surgery
Surgical Approach
Chart review to determine anterior or posterior approach
Measured: Minimum 2 years post surgery
Implant demographics
Chart review to determine type of bearing in Versafit DM
Measured: Minimum 2 years post surgery
Complications
Chart review to determine adverse events and serious adverse events
Measured: Minimum 2 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start1 Mar 2017
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthritisStudies 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
- Retrospective
- Enrolment
- 316 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
- NCT03897387
- Sponsor's protocol ID
- MUSA-H-VDM-001
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2019
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market, Multi-center, Retrospective Study to Identify Clinical Outcomes and Complications Data From Patients Implanted With the Medacta Versafit Cup DM Prosthesis Who Are at Least Two Years Post Surgery
- ClinicalTrials.gov ID
- NCT03897387
- Acronym / sponsor ID
- MUSA-H-VDM-001
- Conditions
- Hip Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Medacta USAIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 1 Apr 2019 (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-market, retrospective with one prospective visit, multi- center study, designed to assess the clinical outcomes, surgical details including Anterior or Posterior surgical approach, and collect all complication data of Medacta Versafit Cup DM used for primary or revision total hip arthroplasty at minimum two year post- operatively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to a total of 528 qualified patients who have undergone primary or revision Total Hip Arthroplasty (THA) will be enrolled.
Key inclusion criteria (3 listed)
- Subjects age 18 years and above at the time of consent
- Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol. Written informed consent must be obtained prior to any study procedure. 3 Patients must be willing to comply with the prospective visit schedule.
- 4. Patient underwent a primary or revision total hip replacement for any etiology (osteoarthritis, avascular necrosis, inflammatory arthritis, post- traumatic arthritis, hip fracture, failed prior procedures, etc.). 5. Patients must have received a Medacta Versafit Cup DM component 6. Patient must have adequate pre-operative and post-operative radiographs 7. Patients must be at minimum 2 year (24 months) post-treatment 8. The operation was performed by the investigator.
Key exclusion criteria (7 listed)
- History of alcoholism
- Currently on chemotherapy or radiation therapy
- Habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than hip pain
- History of a metabolic disorder such as Gout affecting the skeletal system other than osteoarthritis or osteoporosis
- History of chronic pain issues for reasons other than hip pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dislocation rate of Medacta Versafit Cup DM
Time frame: Minimum 2 years post surgery
Determine radiographic analysis of component position in millimeters
Implant position fixation and wear
Time frame: Minimum 2 years post surgery
Determine by radiographic analysis by measuring Radio Lucent lines in millimeters
Limb length
Time frame: Minimum 2 years post surgery
Determined by radiographic analysis by measuring in millimeters
Patient Satisfaction and outcome score
Time frame: Minimum 2 years post surgery
Determined by the Hip Disability and Osteoarthritis Outcome Score (HOOS) likert scale score
9 secondary outcomes
Patient questionnaire Forgotten Joint Score (FJS)
Time frame: Minimum 2 years post surgery
Patient questionnaire Harris Hip Score (HHS)
Time frame: Minimum 2 years post surgery
Patient questionnaire Likert Scale Score
Time frame: Minimum 2 years post surgery
Gait analysis
Time frame: Minimum 2 years post surgery
Range of Motion
Time frame: Minimum 2 years post surgery
Implant survivorship
Time frame: Minimum 2 years post surgery
Surgical Approach
Time frame: Minimum 2 years post surgery
Implant demographics
Time frame: Minimum 2 years post surgery
Complications
Time frame: Minimum 2 years post surgery
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 1 Apr 2022.
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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.
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 Hip Arthritis, 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 3 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 1 Apr 2022. 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?
Dislocation rate of Medacta Versafit Cup DM (time frame: Minimum 2 years post surgery). The study lists 4 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 1 Apr 2022.