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H-28 DELTA ST-C and Minima Retrospective Study.

Sponsor
Limacorporate S.p.a (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05014113
Collaborator
(none)
95
Enrollment
1
Location
18.5
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: DELTA-ST cup in combination with MINIMA stem

Study Design

Study Type:
Observational
Anticipated Enrollment :
95 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
A Retrospective Study Evaluating Clinical and Radiographic Early Outcomes of Total Hip Arthroplasty With DELTA ST-C Cup and MINIMA Stem.
Actual Study Start Date :
Sep 15, 2020
Anticipated Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
Mar 31, 2022

Outcome Measures

Primary Outcome Measures

  1. Harris Hip Score (HHS) [Pre-operative - Month 36]

    Assessment of Harris Hip Score from pre-operative baseline up to 3 years after surgery

Secondary Outcome Measures

  1. Stability assessment of DELTA ST-C cup [At discharge - Month 36]

    Radiographic analysis and stability assessment of the DELTA ST-C cup as rate of symptomatic radiolucent lines, loosening, and subsidence ≥ 2 mm from discharge (baseline) up to 3-year follow-up

  2. Stability assessment of MINIMA stem [At discharge - Month 36]

    Radiographic analysis and stability assessment of the MINIMA stem as rate of symptomatic radiolucent lines, loosening, and subsidence ≥ 2 mm from discharge (baseline) up to 3-year follow-up

  3. Survival rate of the implant [Month 36]

    The survival rate of the implant is expressed by Kaplan-Meier estimator

  4. Safety assessment (adverse events) [Intra-operative - Month 36]

    Assessment of any possible adverse device event or device-related complication detected and recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Psychiko Clinic (Athens Medical Group) Athens Psychiko Greece 115 25

Sponsors and Collaborators

  • Limacorporate S.p.a

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Limacorporate S.p.a
ClinicalTrials.gov Identifier:
NCT05014113
Other Study ID Numbers:
  • H-28
First Posted:
Aug 20, 2021
Last Update Posted:
Aug 20, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Osteoarthritis, Hip

Study Results

No Results Posted as of Aug 20, 2021