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

NCT03168750 | Completed FDA Device

• 1 other identifier: MUSA-H-ML-001
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (1)

• Radiographic analysis

  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.

Study Arms (1)

Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup

All patients enrolled will receive the Medacta Masterloc Stem and MPACT cup with Highcross PE liner.

Device: Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup.

Interventions

Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup. DEVICE

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.

Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery as part of routine care.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medacta USA: lead

Study Sites (3)

Tucson Othropedic Institute

Oro Valley, Arizona, 85755, United States

Location

Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence

West Jordan, Utah, 84088, United States

Location

Spokane Joint Replacement Center

Spokane, Washington, 99218, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 30, 2017
• Study Start: July 25, 2017
• Primary Completion: November 13, 2024
• Study Completion: November 13, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

US (3)