Ceramic hip resurfacing vs total hip replacement

Phase 4

Conditions: Osteoarthritis, hip inflammatory arthritis
Musculoskeletal Diseases

Registration Number: ISRCTN10665654

Lead Sponsor: Embody Orthopaedic

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 200

Inclusion Criteria

1. Patient requires unilateral primary hip arthroplasty due to primary osteoarthritis, osteoarthritis secondary to e.g. trauma, avascular necrosis or developmental hip dysplasia, or inflammatory arthritis
2. Patient is willing to comply with study requirements
3. Patient plans to be available through 24 months postoperative follow-up

Exclusion Criteria

1. Patient has a BMI greater than 40 kg/m²
2. Patient has active infection or sepsis (treated or untreated)
3. Patient has insufficient bone stock at the hip (>1/3 necrosis of the femoral head or large and multiple cysts) or in general as in severe osteopenia or osteoporosis (Tscore < -2.5 as measured with BMD)
4. Patient is not skeletally mature
5. Patient meets the contraindication criteria of the control device
6. Patient already has another lower limb arthroplasty or arthrodesis or will require a further lower limb arthroplasty or arthrodesis within the subsequent 2 years
7. Patient lacks capacity to consent
8. Patient is unable to understand the native language of the country where their procedure is taking place

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical success measured using a composite clinical success score at 0, 6 weeks, 6, 12 and 24 months and 3, 5 and 10 years.

Secondary Outcome Measures

Name	Time	Method
1. Physical activity measured using a wearable activity tracker at 6, 12 and 24 months<br>2. Physical performance measured using physical performance assessments at baseline, 6, 12 and 24 months<br>3. Activity measured using the patient-reported outcome measure (PROM) Hip Outcome Score (HOS) at baseline, 6 weeks, 6, 12 and 24 months<br>4. Activity measured using the PROM UCLA Activity Score at baseline, 6 weeks, 6, 12 and 24 months<br>5. Noise measured using a Noise Survey at 6 weeks, 6, 12 and 24 months