Clinical trial NCT05014113: H-28 DELTA ST-C and Minima Retrospective Study.
Official title: A Retrospective Study Evaluating Clinical and Radiographic Early Outcomes of Total Hip Arthroplasty With DELTA ST-C Cup and MINIMA Stem.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis, Hip
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
First posted: 2021-08-20
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of 95 consecutive patients who underwent to a THA with DELTA ST-C cup in combination with MINIMA stem in 2017 onwards at the Psychiko Clinic and are compliant with all the Inclusion and Exclusion criteria.

Brief summary: The study aims to assess the clinical and radiographic outcomes of DELTA ST-C in combination with MINIMA stem at 3 years after primary THA surgery, and to evaluate the overall survivorship of the implant.


Eligibility criteria: Inclusion Criteria:

* Underwent to a THA with DELTA ST-C cup and MINIMA stem in 2017 onwards
* Both genders
* Any race
* A diagnosis in the target hip of one or more of the following:

  1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis
  2. Rheumatoid Arthritis
  3. Post-traumatic arthritis
  4. Fractures of femoral neck
  5. Congenital or acquired deformity
* Patient willingness to participate

Exclusion Criteria:

* Local or systemic infection
* Septicaemia
* Persistent acute or chronic osteomyelitis
* Confirmed nerve or muscle lesion compromising hip joint function
* Vascular or nerve diseases 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 prosthesis
* Metal hypersensitivity to implant materials
* Required revision of previous standard femoral stem
* Age \< 18 years old
* Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation including, but not limited to:

  1. significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery
  2. neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
  3. known metabolic disorders leading to progressive bone deterioration
* Hip replacement on the contralateral side performed within less than one year

Primary outcomes:
measure: Harris Hip Score (HHS)
timeFrame: Pre-operative - Month 36
Secondary outcomes:
measure: Stability assessment of DELTA ST-C cup
timeFrame: At discharge - Month 36
measure: Stability assessment of MINIMA stem
timeFrame: At discharge - Month 36
measure: Survival rate of the implant
timeFrame: Month 36
measure: Safety assessment (adverse events)
timeFrame: Intra-operative - Month 36
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Psychiko Clinic (Athens Medical Group)
state: Psychiko
Study officials:
References: