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

NCT05014113 | Unknown

• 1 other identifier: H-28
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

• Harris Hip Score (HHS)

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

  Pre-operative - Month 36

Secondary Outcomes (4)

• Stability assessment of DELTA ST-C cup

  At discharge - Month 36

• Stability assessment of MINIMA stem

  At discharge - Month 36

• Survival rate of the implant

  Month 36

• Safety assessment (adverse events)

  Intra-operative - Month 36

Interventions

DELTA-ST cup in combination with MINIMA stem DEVICE

Advance articular destruction generated by primary degenerative or post-traumatic arthrosis or reumatoid arthritis; fracture or avascular necrosis; congenital or acquired deformity.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis
• Rheumatoid Arthritis
• Post-traumatic arthritis
• Fractures of femoral neck
• Congenital or acquired deformity
• Patient willingness to participate

You may not qualify if:

• 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:
• significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery
• neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
• known metabolic disorders leading to progressive bone deterioration

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (1)

Psychiko Clinic (Athens Medical Group)

Athens, Psychiko, 115 25, Greece

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Fabiana Pavan

CONTACT

+393485816391; fabiana.pavan@limacorporate.com

Federica Azzimonti

CONTACT

+393775450940; federica.azzimonti@limacorporate.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 20, 2021
• Study Start: September 15, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

GR (1)