A Prospective Randomized Clinical Study Evaluating the Outcomes of MINIMA Stem With DELTA TT or DELTA ST-C Cup After Total Hip Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Harris Hip Score (HHS)
Study Overview
Brief Summary
This study is aimed to provide a clinical and radiographic evaluation of 120 suitable subjects who underwent a total hip arthroplasty with MINIMA stem coupled with Delta TT or Delta ST-C cup.
Detailed Description
This is a post-market, interventional, prospective, randomized, not comparative, open label study designed to reflect real life clinical practice as closely as possible.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Both genders
- •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
Arms & Interventions
Minima Stem with ST-c Cup
Minima Stem with ST-c Cup
Intervention: TT cup and ST-C cup (Device)
Minima Stem with TT Cup
Minima Stem with TT Cup
Intervention: TT cup and ST-C cup (Device)
Outcomes
Primary Outcomes
Harris Hip Score (HHS)
Time Frame: 3 years
Functional changes in Harris Hip Score (HHS) from preoperative (baseline) to 3 years after surgery
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.
Secondary Outcomes
- Implant stability(6 months, 1 year, 3 years, 5 years after surgery)
- Oxford Hip Score (OHS)(5 years)
- Survival Rate(5 years)
- Forgotten Joint Score (FJS)(3 months (baseline) to 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery)
- Safety assessment(Intra operative, 3 months, 6 months, 1 year, 3 years, 5 years)
- Harris Hip Score (HHS)(5 years)
- Oxford Hip Score (OHS)(Pre-operative, 3 months, 6 months, 1 year, 3 years, and 5 years)