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Trial record 1 of 1 for:    NCT04322916
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Clinical Study With the RM Pressfit Vitamys Cup in Combination With a Mathys Stem

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ClinicalTrials.gov Identifier: NCT04322916
Recruitment Status : Active, not recruiting
First Posted : March 26, 2020
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Mathys Ltd Bettlach

Brief Summary:
The purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the RM Pressfit vitamys cup. The data will be used for an ongoing evaluation of the product safety and performance.

Condition or disease Intervention/treatment
Arthropathy of Hip Hip Replacement Device: RM Pressfit vitamys

Detailed Description:

Prospective multicenter follow-up study which examines the short- to long-term post-market clinical data on the safety and performance of the RM Pressfit vitamys cup. In total 675 participants in 9 clinics are included in this international multicenter study.

The primary endpoint of the study is the Harris Hip Score (HHS) 2 years after surgery.

The following parameters will be collected during the regular clinical and radiological follow-up: Harris Hip Score, radiographic evaluation and detection of adverse events.

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Study Type : Observational
Actual Enrollment : 675 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Study With the RM Pressfit Vitamys Cup in Combination With a Mathys Stem
Actual Study Start Date : September 15, 2009
Actual Primary Completion Date : March 28, 2012
Estimated Study Completion Date : April 2022

Group/Cohort Intervention/treatment
RM Pressfit vitamys
Participants treated with a RM Pressfit vitamys hip cup in combination with a Mathys hip stem
Device: RM Pressfit vitamys
Implantation of a RM Pressfit vitamys hip cup




Primary Outcome Measures :
  1. Harris Hip Score (modified after Haddad et al, 1990) [ Time Frame: 2 years ]
    The primary endpoint of the study is the Harris Hip Score (HHS) 2 years after surgery. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.


Secondary Outcome Measures :
  1. Radiographic evaluation [ Time Frame: 6-12 weeks - 10 years ]
    The second endpoint of interest is the occurence of osteolysis around the cup

  2. Adverse Events [ Time Frame: 6-12 weeks - 10 years ]
    Reporting of Adverse Events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
according to Eligibility Criteria
Criteria

Inclusion Criteria:

  • Informed consent form (signed by participant and investigator)
  • Primary implantation
  • Age at inclusion: Between 18 and 95 years old
  • Willing to participate in the follow-up

Exclusion Criteria:

  • Missing Informed consent form
  • Known or suspected non-compliance (e.g. drug or alcohol abuse)
  • Enrollment of the investigator, his/her family, employees and other dependent persons
  • Patient younger than 18 years old
  • Revision surgery
  • Presence of sepsis or malignant tumors
  • Pregnancy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mathys Ltd Bettlach
ClinicalTrials.gov Identifier: NCT04322916    
Other Study ID Numbers: 20081020_Protocol_E_vitamys_V1
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mathys Ltd Bettlach:
Primary osteoarthritis
Secondary osteoarthritis
Inflammatory arthritis
Congenital dysplasia
Femoral head fracture
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases