Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study

Hip Replacement Clinical Trial

Official title:

Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06172569
• Other study ID #: 111-440-100
• Status: Recruiting
• Start date: December 8, 2023
• Est. completion date: April 1, 2028

Study information

• Verified date: December 2023
• Source: Signature Orthopaedics
• Contact: Satish Shejale, MS Ortho
• Phone: +61 02 9428 5181
• Email: satish.shejale[@]signatureortho.com.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to monitor the performance of the Signature Orthopaedics Spartan Stem, World Acetabular Cup and World Liner as a post-market vigilance and continuous improvement efforts.

Description:

The objective of this PMCF Study is to collect data confirming safety, performance and clinical benefits of the Spartan Stem, World Acetabular Cup and the World Liner when used for primary total hip arthroplasty at 2-years follow-up. The study includes pre-operative, operative, discharge, 1 year post-operative evaluations, where data concerning the performance and safety of the device are gathered. The revision rate of the components will be monitored as the primary objective, along with pre and post operative measurement of the Oxford Hip Score (OHS), patient-reported outcome measure (PROM) to quantify patient satisfaction. Radiography analysis will be done to monitor bony response to the implant and qualify the effectiveness of the cementless fixation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 1, 2028
• Est. primary completion date: April 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patient requires unilateral primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g., osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia/DDH)
• patient must be a candidate for use of the products studied, as determined jointly by the surgeon and patient.
• male and non-pregnant female patients aged 18-75
• patients who understand the conditions of the clinical evaluation and are willing to participate for the length of the prescribed follow-up.

Exclusion Criteria:

• patient has active infection or sepsis(treated or untreated) enough to compromise implant stability or postoperative recovery
• patient is a female of child-bearing age and not taking and not taking contraceptive pills
• patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
• patient has a known or suspected metal sensitivity
• patient is immuno-suppressed with disease such as AIDS or is receiving high dose of cortico-steroids.
• patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the clinical evaluation including mental illness, mental retardation or drug abuse
• patient is severely overweight with a BMI>40.

Related Conditions & MeSH terms

• Hip Replacement

Intervention

Device:
• Spartan Stem, World Acetabular Cup and World Liner
The Spartan Stem is a wedge-shaped fit and fill design stem with Titanium Plasma Spray(TPS) and Hydroxyapatite (HA) coating. The World Acetabular cup is Porous coated and mated with cross-linked polyethylene World Liner

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Signature Orthopaedics	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Radiographic Analysis	Post-operative radiographs of the implant are analysed to identify locations and sizes of radiolucency, indicative of poor fixation. The size, location and progression of radiolucency is monitored. Smaller, non-progressive radiolucencies are preferred.	up to 2 years.
Primary	Spartan Stem, World Acetabular Cup and World Liner Survival Rate	The implant survival rate is based on removal of the device for any reason as determined following the Kaplan-Meier method.	up to 2 years
Secondary	Oxford Hip Score (OHS)	The OHS is a patient reported outcome measure (PROM) used to quantify patient satisfaction with the treatment. It consists of 12 questions scored 1 to 5 by the patient.	up to 2 years