A Randomized Controlled Trial Comparing Modular Dual Mobility Inserts With Ceramic Multilayer Coating Versus Standard Polyethylene Inserts for Primary Total Hip Arthroplasty (THA) in a Cementless Acetabular Cup
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Aesculap AG
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Serum metal ion analysis (Chromium)
Study Overview
Brief Summary
A randomized controlled trial comparing modular dual mobility inserts with ceramic multilayer coating versus standard polyethylene inserts for primary THA in a cementless acetabular cup
Detailed Description
The aim of this study is to show in a randomized controlled trial that cobalt and chromium ion serum levels are comparable to the metal ion levels in patients with standard articulation with metal head. The metal on polyethylene articulation is accepted as standard articulation since many decades, and which is currently in the Czech Republic the most used combination. Most studies which focused on the topic of metal ion release from modular dual mobility systems do not present results of a control group with standard articulation hip implants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Primary coxarthrosis patients indicated for cementless total hip arthroplasty
- •Written informed patient consent
Exclusion Criteria
- •Hip trauma or revision surgery
- •Rheumatoid or neurologic disease
- •Ongoing oncologic therapy
- •Preoperatively elevated Co or Cr serum levels >1.0 µg/L
- •Patients with other joint implants, or anticipated need for another joint replacement surgery within the study period
- •Acetabular cup size <52 expected
- •Patients not able to mentally or physically comply with the study demands and follow-up visits
- •Patients <18 years at surgery
- •Pregnancy
Outcomes
Primary Outcomes
Serum metal ion analysis (Chromium)
Time Frame: 12 months after surgery
Chromium ion levels in blood serum in measured in \[µg/L\], Comparison between the two groups
Serum metal ion analysis (Cobalt)
Time Frame: 12 months after surgery
Cobalt ion levels in blood serum in measured in \[µg/L\], Comparison between the two groups
Secondary Outcomes
- Radiologic Evaluation: center of rotation(immediately postoperative, 3 months, 12 months and 3 years postoperative)
- Radiologic Evaluation: Radiolucencies around the cup(over follow-up period 3 months, 12 months and 3 years postoperative)
- Radiological Outcome: Heterotopic Ossification(over follow-up period 3 months, 12 months and 3 years postoperative)
- Change of functional outcome over three year follow-up period (Harris Hip Score)(3 months, 12 months and 3 years postoperatively)
- Gait analysis over time(preoperative, 3 months and 12 months postoperatively)
- Development of Patient satisfaction with surgery result over time(at three examinations during Follow-Up (3 months postop, 1 year postop, 3 years postop))
- Radiologic Evaluation: Cup Inclination over time(immediately postoperative, 3 months, 12 months and 3 years postoperative)