DELTA Multihole TT Study

Hip Osteoarthritis Clinical Trial

Official title:

A Retrospective Study Evaluating Clinical and Radiographic Early Outcomes of Total Hip Arthroplasty and Revision Hip Arthroplasty With DELTA Multihole TT Cup.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04375345
• Other study ID #: UHBratislava
• Status: Recruiting
• Start date: January 23, 2020
• Est. completion date: March 23, 2022

Study information

• Verified date: May 2020
• Source: University Hospital Bratislava
• Contact: Boris Steno, MD PhD Prof
• Phone: +421905512004
• Email: bosten1[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A retrospective study evaluating clinical and radiographic early outcomes of total hip arthroplasty and revision hip arthroplasty with DELTA Multihole TT cup.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 23, 2022
• Est. primary completion date: January 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

IInclusion criteria as per DELTA Multihole TT indications for use:

Age = 18 years

• Non-inflammatory degenerative joint disease such as osteoarthritis or avascular necrosis;

• Signed Informed consent

• Hip dislocation using protruded liners, spacers;

• Rheumatoid arthritis;

• Post-traumatic arthritis;

• Correction of functional deformity in case of acetabulum verticalization, anteversion, and retroversion;

• Fractures of femoral neck;

If used in combination with spacers and hemispheric modules, other indications are:

• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure;

• Clinical management problem where arthrodesis or alternative reconstruction techniques are less likely to achieve satisfactory results;

• Where bone stock is of poor quality or is inadequate for other reconstruction techniques as indicated by deficiencies of the acetabulum.

Exclusion criteria as per DELTA Multihole TT contraindications for use:

• Local or systemic infections;

• 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 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.

Additional exclusion criteria:

• Female patients who are pregnant, nursing, or planning a pregnancy.

Related Conditions & MeSH terms

• Arthroplasty Complications
• Hip Dislocation
• Hip Dislocation, Congenital
• Hip Dysplasia
• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• hip arthroplasty
complex primary total hip arthroplasty or revision total hip arthroplasty performed through anterolateral or posterolateral approach

Locations

Country	Name	City	State
Slovakia	2nd University Department of Orthopaedic and Trauma Surgery Comenius University Faculty of Medicine	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Bratislava

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of HHS score equal or greater than "Good" at 2 years after surgery		Month 24
Secondary	Radiographic implant evaluation and stability assessment	Migration over 2 mm or over 5 degrees	Week 6, Week 12, Month 6, Month 12, Month 24
Secondary	Survival rate	Kaplan-Meier	Month 24
Secondary	Patients recovery at 2 years after surgery evaluated using the 5-level EQ-5D version (EQ-5D-5L).	The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).	Month 24
Secondary	Incidence of device-related Adverse Events / Serious Adverse Events		Intraoperative, Week 6, Week 12, Month 6, Month 12, Month 24