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

Osteoarthritis, Hip Clinical Trial

Official title:

A Retrospective Study Evaluating Clinical and Radiographic Early Outcomes of Total Hip Arthroplasty With DELTA ST-C Cup and MINIMA Stem.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05014113
• Other study ID #: H-28
• Status: Recruiting
• Start date: September 15, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: August 2021
• Source: Limacorporate S.p.a
• Contact: Fabiana Pavan
• Phone: +393485816391
• Email: fabiana.pavan[@]limacorporate.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

Device:
• DELTA-ST cup in combination with MINIMA stem
Advance articular destruction generated by primary degenerative or post-traumatic arthrosis or reumatoid arthritis; fracture or avascular necrosis; congenital or acquired deformity.

Locations

Country	Name	City	State
Greece	Psychiko Clinic (Athens Medical Group)	Athens	Psychiko

Sponsors (1)

Lead Sponsor	Collaborator
Limacorporate S.p.a

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris Hip Score (HHS)	Assessment of Harris Hip Score from pre-operative baseline up to 3 years after surgery	Pre-operative - Month 36
Secondary	Stability assessment of DELTA ST-C cup	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	At discharge - Month 36
Secondary	Stability assessment of MINIMA stem	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	At discharge - Month 36
Secondary	Survival rate of the implant	The survival rate of the implant is expressed by Kaplan-Meier estimator	Month 36
Secondary	Safety assessment (adverse events)	Assessment of any possible adverse device event or device-related complication detected and recorded	Intra-operative - Month 36