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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Hip
• Intervention / Treatment: Device: DELTA-ST cup in combination with MINIMA stem

• Study Type: Observational
• Enrollment (Anticipated): 95

Contacts and Locations

• Study Contact: Name: Fabiana Pavan; Phone Number: +393485816391; Email: fabiana.pavan@limacorporate.com
• Study Contact Backup: Name: Federica Azzimonti; Phone Number: +393775450940; Email: federica.azzimonti@limacorporate.com

Study Locations

• Greece
  • Psychiko
    • Athens, Psychiko, Greece, 115 25
      • Recruiting
      • Psychiko Clinic (Athens Medical Group)
      • Contact: Angeliki Syrigou
      • Principal Investigator: Nikolaos Christodoulou
      • Sub-Investigator: Karatzas Voutsas
      • Sub-Investigator: Emmanouil Volonakis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score (HHS)	Assessment of Harris Hip Score from pre-operative baseline up to 3 years after surgery	Pre-operative - Month 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Survival rate of the implant	The survival rate of the implant is expressed by Kaplan-Meier estimator	Month 36
Safety assessment (adverse events)	Assessment of any possible adverse device event or device-related complication detected and recorded	Intra-operative - Month 36

Collaborators and Investigators

• Sponsor: Limacorporate S.p.a

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: H-28

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No