Analysis of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component

Osteoarthritis, Hip Clinical Trial

Official title:

Prospective, Multicenter Study to Assess Performance of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component in Total Hip Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03168750
• Other study ID #: MUSA-H-ML-001
• Status: Active, not recruiting
• Start date: July 25, 2017
• Est. completion date: May 1, 2024

Study information

• Verified date: June 2023
• Source: Medacta USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This prospective study will evaluate the hip function and quality of life of patients operated for total hip arthroplasty with Masterloc femoral stem and MPACT acetabular cup. The results of this study will establish the performance of Masterloc femoral component (Medacta International SA) and MPACT acetabular component (Medacta International SA), and provide a general estimate of survivorship, clinical effectiveness and complications.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: May 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 75 Years

Eligibility

Inclusion Criteria:

• Primary osteoarthritis of the hip necessitating primary hip replacement,

• Suitability for straight cementless stem,

• Adult male and female under 75 years old,

• Ability to give informed consent ,

• Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up.

Exclusion Criteria:

• Off-label use of the Medacta Masterloc femoral component and MPACT acetabular component

• Post-traumatic deformity in the affected hip,

• Patient suffering from Inflammatory arthritis including rheumatoid arthritis,

• Patient suffering by congenital or developmental deformity,

• Severe osteoporosis,

• History of surgery in the affected hip,

• Perioperative fracture,

• Personality disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain,

• Patients with a history of active infection

• Pregnant women or those seeking to become pregnant

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

Device:
• Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup.
Total hip arthroplasty (THA) is one of the most commonly performed and successful orthopaedic operations in improving a patient's quality of life. Orthopaedic surgeons are continually striving to improve all aspects of care relating to this procedure whether this is improvements in implant technology, instrument improvement, or the technique involved in performing the procedure.The results of this study will establish the performance of the femoral component and acetabular component, and provide a general estimate of survivorship, clinical effectiveness and complications.

Locations

Country	Name	City	State
United States	Tucson Othropedic Institute	Oro Valley	Arizona
United States	Spokane Joint Replacement Center	Spokane	Washington
United States	Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Medacta USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris Hip Score (HHS)	Assessment of the improvement of clinical outcomes following total hip replacement using the Harris Hip Score	pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Primary	Hip Disability and Osteoarthritis Outcome Score (HOOS)	Assessment of the improvement in activity levels following total hip replacement using the Hip Disability and Osteoarthritis Outcome Score	pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Primary	Oxford Hip Score (OHS)	Assessment of the improvement in the patients physical level of activity using the Oxford Hip Score	pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Primary	Veterans Rand 12 (VR-12)	Assessment of the improvement in your health using the Veterans Rand 12	pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Primary	EuroQol 5 dimension (EQ-5D)	Assessment of the improvement in quality of life and joint movement using the EQ-5D	pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.
Secondary	Radiographic analysis	Radiographic analysis will include evaluation of osteolysis, radiolucent lines, bone hypertrophy, component migration, heterotopic ossification, resorption of calcar.	pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.