Ceramic Modular Dual Mobility in Primary Total Hip Arthroplasty (THA)

Browse trials for

• Osteoarthritis, Hip 628

Keywords

• Dual Mobility Cup
• Total Hip Arthroplasty

Osteoarthritis, Hip

628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.

This study's planned enrollment of 100 is above the median of 90 across 450 interventional studies indexed under Osteoarthritis, Hip.

Lead sponsor

Aesculap AG is the lead sponsor of 104 studies on the registry; 20 are open to participants now.

Study arms

• Experimental
  Dual Mobility Cup

  dual mobility articulation

  Device: Dual Mobility Cup

• Active comparator
  Standard Acetabular component

  standard articulation with polyethylene + vitamin E inlay and metal head

  Device: Standard Acetabular component

Interventions

• DeviceDual Mobility Cup

  Total 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

  Also known as: Total Hip Arthroplasty

• DeviceStandard Acetabular component

  Total 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

  Also known as: Total Hip Arthroplasty

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 surgery

2. 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 surgery

Secondary 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 postoperatively

2. 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 postoperatively

3. 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 postoperative

5. Radiologic Evaluation: center of rotation

   Centre of Rotation (CoR) is defined as the zero position for the measurement of potential cup migration. Horizontal: Distance of CoR to ipsilateral teardrop; Vertical: Distance CoR to Inter-teardrop line; The comparison of the intraoperatively center of rotation and the center of rotation at different follow-up examinations allows prediction on longterm success.

   Time frame: immediately postoperative, 3 months, 12 months and 3 years postoperative

6. Radiologic Evaluation: Radiolucencies around the cup

   Bony Osseointegration or conspicuous features of the cup are assessed on anterior-posterior and lateral x-rays of the cup and will be analysed according to the zones defined by Charnley. "Charnley" zones of the acetabular component are distinct zones used in assessment of aseptic loosening in total hip joint replacements. The radiolucencies are categorized to "none", "less than or equal to 2mm" and "more than 2 mm"

   Time frame: over follow-up period 3 months, 12 months and 3 years postoperative

7. Radiological Outcome: Heterotopic Ossification

   Brooker classification divides heterotopic ossifications that form following total hip replacement to four classes. Class I: islands of bone within soft tissues around hip; Class II: bone spurs in pelvis or proximal end of femur leaving ≥1 cm between the opposing bone surfaces; Class III: bone spurs that extend from pelvis or the proximal end of femur, which reduce the space between the opposing bone surfaces to \<1cm; Class IV: ankylosis of the hip on x-ray

   Time frame: over follow-up period 3 months, 12 months and 3 years postoperative