DELTA Multihole TT Study

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

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

Study Overview

• Status: Unknown
• Conditions: Hip Dysplasia; Hip Osteoarthritis; Arthroplasty Complications
• Intervention / Treatment: Device: hip arthroplasty

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Slovakia
  • Bratislava, Slovakia, 85107
    • Recruiting
    • 2nd University Department of Orthopaedic and Trauma Surgery Comenius University Faculty of Medicine

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: Non-Probability Sample

Study Population

Study participants will be selected from patients who underwent a Total Hip Arthroplasty with the DELTA Multihole TT cup. Both complex primary and revision cases are considered.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of HHS score equal or greater than "Good" at 2 years after surgery	Month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic implant evaluation and stability assessment	Migration over 2 mm or over 5 degrees	Week 6, Week 12, Month 6, Month 12, Month 24
Survival rate	Kaplan-Meier	Month 24
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
Incidence of device-related Adverse Events / Serious Adverse Events		Intraoperative, Week 6, Week 12, Month 6, Month 12, Month 24

Collaborators and Investigators

• Sponsor: University Hospital Bratislava
• Investigators: Principal Investigator: Boris Steno, MD PhD Prof, University Hospital Bratislava

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2020
• Primary Completion (Anticipated): January 23, 2022
• Study Completion (Anticipated): March 23, 2022

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: total hip arthroplasty; hip arthroplasty revision; complex primary arthroplasty; trabecular titanium
• Additional Relevant MeSH Terms: Wounds and Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Osteoarthritis; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Osteoarthritis, Hip
• Other Study ID Numbers: UHBratislava

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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