The purpose of this study is to assess the early and long term safety and efficacy of the hard-on-hard total hip replacement system (R3 ODH-ODH utilization) in patients with non-inflammatory arthritis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Entabeni Hospital
Durban, South Africa
Zuid Afrikaans Hospital
Pretoria, South Africa
Number of Participants With Device-Related Revisions
Device related revisions reported by the number of participants with a revision required (Yes/No).
Time frame: Postoperatively through 10 years
Metal Ion Concentration in Whole Blood
For both investigational (i.e., Investigational Hard-on-Hard Total Hip Replacement Device) and control (i.e., Control Total Hip Replacement Device) participants, metal ion concentration in whole blood were measured for Cobalt (Co), Chromium (Cr), Nickel (Ni), Titanium (Ti), Zirconium (Zr), Niobium (Nb), Molybdenum (Mo), Vanadium (V) and Aluminum (Al) at each indicated time frame.
Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.
Harris Hip Score (HHS) - Investigational Hard-on-Hard Total Hip Replacement Device Only
The Harris Hip Score (HHS), which ranges from 0 (worst) to 100 (best), considers information on pain, function, and range of motion. HHS was measured for Investigational Hard-on-Hard Total Hip Replacement Device only.
Time frame: Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operatively.
Hip Disability and Osteoarthritis Outcome Scores (HOOS)
The Hip Disability and Osteoarthritis Outcome Scores (HOOS) was measured for Investigational Hard-on-Hard Total Hip Replacement Device only and included 40 items with five responses from five subcategories of Pain, Symptoms and Stiffness, Activities of Daily Living, Function in Sports and Recreational Activities, and Quality of Life to produce a total HOOS. The total HOOS scale ranged from 0 to 100, with 0 indicating the worst possible score and 100 indicating the best possible score.
Time frame: Preoperatively, 3 months, 6 months, 1 year, 2 years, 5 years, 7 years, 10 years
Radiographic Measures: Radiolucencies
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Radiolucencies determined by number of participants with occurrence of radiolucent lines and osteolysis (Yes/No)
Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative
Radiographic Measures: Heterotopic Ossification
Occurrence of Heterotopic Ossification in participants (Yes/No)
Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative
Radiographic Measures: Subsidence
Occurrence of Subsidence in Investigational Hard-on-Hard Total Hip Replacement Device participants (Yes/No) categorized by: * Acetabular Cup Subsidence * Stem Subsidence * Evidence of cortical thickening * Acetabular component fail * Femoral component fail * Other
Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 7 years and 10 years post-operative
Health Economic Outcomes: Surgical Blood Loss
Blood loss during surgery measured in milliliters (ml) of blood
Time frame: Intra-operative, up to 50 minutes
Health Economic Outcomes: Length of Hospital Stay
Length of stay measured by number of days spent in hospital
Time frame: Hospital admission to discharge
Health Economic Outcomes: Operative Time
Operative time in minutes from first incision into skin to time when last suture is applied for the Investigational Hard-on-Hard Total Hip Replacement Device group only
Time frame: Intra-operative
Health Economic Outcomes: Re-Hospitalizations
Re-hospitalizations measured by the number of re-admissions to hospital
Time frame: Up to 10 years