Ceramic Modular Dual Mobility in Primary Total Hip Arthroplasty (THA)
ConditionCoxarthrosis; Primary
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAesculap AG
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary coxarthrosis patients indicated for cementless total hip arthroplasty
Written informed patient consent
Disqualifiers
Hip trauma or revision surgery
Rheumatoid or neurologic disease
BMI >35
Ongoing oncologic therapy
Trial design
Design model
Parallel
Treatments tested in this trial
Dual Mobility Cup
DeviceTotal hip arthroplasty (THA) is a successful and established therapy for coxarthrosis, rheumatic arthritis, hip fractures and femoral head necrosis. The acetabular implant for this arm is the Dual Mobility cup
Standard Acetabular component
DeviceTotal hip arthroplasty (THA) is a successful and established therapy for coxarthrosis, rheumatic arthritis, hip fractures and femoral head necrosis. The acetabular implant for this arm is the standard device with polyethylene + vitamin E inlay and metal head
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Dual Mobility CupExperimental treatment 1 intervention
Group B: Standard Acetabular componentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Serum metal ion analysis (Cobalt)
Cobalt ion levels in blood serum in measured in \[µg/L\], Comparison between the two groups
Time frame
12 months after surgery2
Serum metal ion analysis (Chromium)
Chromium ion levels in blood serum in measured in \[µg/L\], Comparison between the two groups
Time frame
12 months after surgerySecondary outcomes
1
Change of functional outcome over three year follow-up period (Harris Hip Score)
The Harris Hip Score (HHS) is one of the most used scores in total hip arthroplasty, mainly combining range of motion questions with questions regarding daily life activities. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100, any result \<70 is considered a poor result; The HHS is an outcome measure administered by a qualified health care professional, such as a physician or a physical therapist.
Time frame
3 months, 12 months and 3 years postoperatively2
Gait analysis over time
The gait lab analysis involves a high amount of recorded data and variables. Gait lab analyses are performed with the patients between the preoperative state, 3 months after surgery and 1 year postoperative. The Gait Profile Score (GPS) is used as a measure for the deviation in gait kinematics from a healthy patient population to compare the two treatment groups. Lower score values can be considered as a sign of better restoration of the physiological gait kinematics.
Time frame
preoperative, 3 months and 12 months postoperatively3
Development of Patient satisfaction with surgery result over time
Patient is asked for satisfaction with surgery result with a 4-point scale: very satisfied, satisfied, unsatisfied, very unsatisfied
Time frame
at three examinations during Follow-Up (3 months postop, 1 year postop, 3 years postop)4
Radiologic Evaluation: Cup Inclination over time
Inclination is the orientation of the cup in the coronal plane. The target acetabular cup inclination is a "safe zone" between 30-50° abduction (assessed on antero-posterior (ap) x-rays of the hip). The comparison of the intraoperatively achieved inclination and the inclination at different follow-up examinations allows prediction on longterm success.
Time frame
immediately postoperative, 3 months, 12 months and 3 years postoperativeSponsors and contacts
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Source ClinicalTrials.gov