MINIMA Stem With DELTA TT or DELTA ST-C Study
A Prospective Randomized Clinical Study Evaluating the Outcomes of MINIMA Stem With DELTA TT or DELTA ST-C Cup After Total Hip Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Martin, Slovakia, 036 59
- The Orthopedic Clinic University Hospital Martin
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both genders
- Any race
- A diagnosis in the target hip of one or more of the following: a) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis; b) rheumatoid arthritis; c) post-traumatic arthritis; d) fractures of femoral neck;
- patien willingness to partecipate and signature of informed consent form
Exclusion Criteria:
- local or systemic infection
- septicaemia
- persistent acute or chronic osteomyelitis
- confirmed nerve or muscle lesion compromising hip joint function
- vascular or nerve disease affecting the concerned limb
- poor bone stock (for example due to osteoporosis) compromising the stability of the implant
- metabolic disorders which may impair fixation and stability of the implant
- any concomitant disease and dependence that might affect the implanted prosthsis
- metal hypersensitivity to implant materials
- required revision of previous standard femoral stem
- women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remail on an acceptable method of birth control throughout the entire study period
- life expectancy less than 5 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Minima Stem with ST-c Cup
|
Patients are allocated in 2 different group (one with ST-C Cup and another one with TT Cup)
|
|
Other: Minima Stem with TT Cup
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Patients are allocated in 2 different group (one with ST-C Cup and another one with TT Cup)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Harris Hip Score (HHS)
Time Frame: Pre-operative, 3 months, 6 months, 1 year and 3 years
|
Functional changes in Harris Hip Score (HHS) from preoperative (baseline) to 3 years after surgery. The Harris Hip Score is composed of ten items covering foru domains: pain, fuction, absence of deformity and range of motion. The maximum score is 100 points. Pain domain contributes 44 points, function 47, Range of Motion 5 and absence of deformity 4 points. Results can be interpreted as follows: less than 60 points corresponds to a failed result, from 60 to 69 to a poor result, from 70 to 79 points to a fair outcome, from 80 to 90 to a good result ad from 90 to 100 to an excellent outcome. Overall, the outcome is considered satisfactory for values over 80 points. |
Pre-operative, 3 months, 6 months, 1 year and 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant stability
Time Frame: 6 months, 1 year, 3 years, 5 years after surgery
|
Radiographic implant evaluation and stability assessment at 6 months, 1 year, 3 years, 5 years after surgery
|
6 months, 1 year, 3 years, 5 years after surgery
|
|
Survival Rate
Time Frame: 5 years
|
Survival rate expressed with Kaplan-Meier estimator at 5 years after surgery
|
5 years
|
|
Safety assessment
Time Frame: Intra operative, 3 months, 6 months, 1 year, 3 years, 5 years
|
Incidence, type, and severity of all the Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) occurred at each follow-up.
|
Intra operative, 3 months, 6 months, 1 year, 3 years, 5 years
|
|
Harris Hip Score (HHS)
Time Frame: 5 years
|
Functional changes in Harris Hip Score (HHS) from preoperative (baseline) to 5 years after surgery. The Harris Hip Score is composed of ten items covering foru domains: pain, fuction, absence of deformity and range of motion. The maximum score is 100 points. Pain domain contributes 44 points, function 47, Range of Motion 5 and absence of deformity 4 points. Results can be interpreted as follows: less than 60 points corresponds to a failed result, from 60 to 69 to a poor result, from 70 to 79 points to a fair outcome, from 80 to 90 to a good result ad from 90 to 100 to an excellent outcome. Overall, the outcome is considered satisfactory for values over 80 points. |
5 years
|
|
Oxford Hip Score (OHS)
Time Frame: Pre-operative, 3 months, 6 months, 1 year, 3 years, and 5 years
|
Functional changes in Oxford Hip Score (OHS) from preoperative (baseline) to 5 years after surgery. The Oxford Hip Score is composed of two domains (pain and function) with six items or questions in each that are scored as follows: each question can be scored from 0 to 4, with 4 being the best outcome, producing overall scores running from 0 to 48, with 48 being the best outcome. The calculation of the total score is based on the above-mentioned scoring system, with a score reported as excellent for more than 41 points, good from 34 to 41, fair from 27 to 33 and poor for less than 27 points. |
Pre-operative, 3 months, 6 months, 1 year, 3 years, and 5 years
|
|
Forgotten Joint Score (FJS)
Time Frame: 3 months (baseline) to 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery
|
Changes in Forgotten Joint Score (FJS) from 3 months (baseline) to 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery. The Forgotten Joint Score is a 12 item questionnaire that integrates variables such as pain, stiffness, function on activities of daily living, ptients' expectations and activity levels and finally psychosocial factors. It consist of 12 questions scored using a 5-point Likert response format (never-almost never-seldom-sometimes-mostly) with raw scores transformed onto a 0-100 point scale. High scores indicate good outcome, that is, a high degree of "forgetting" the joint. |
3 months (baseline) to 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-41
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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