Clinical trial NCT03168750: Analysis of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component
Official title: Prospective, Multicenter Study to Assess Performance of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component in Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Hip
Lead sponsor: Medacta USA
Sponsor class: INDUSTRY
First posted: 2017-05-30
Enrollment: 120
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery as part of routine care.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Harris Hip Score (HHS)
timeFrame: 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.
measure: Hip Disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: 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.
measure: Oxford Hip Score (OHS)
timeFrame: 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.
measure: Veterans Rand 12 (VR-12)
timeFrame: 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.
measure: EuroQol 5 dimension (EQ-5D)
timeFrame: 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:
measure: Radiographic analysis
timeFrame: 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.
Other outcomes:
Locations:
city: Oro Valley
country: United States
facility: Tucson Othropedic Institute
state: Arizona
city: West Jordan
country: United States
facility: Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence
state: Utah
city: Spokane
country: United States
facility: Spokane Joint Replacement Center
state: Washington
Study officials:
References: