H1 Hip Resurfacing Arthroplasty

NCT03326804 | Active Not Recruiting

• 1 other identifier: 213102
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, non-randomized, consecutive series, multicentre, observational study to evaluate the clinical outcome of ceramic-on- ceramic hip resurfacing arthroplasty using the ceramic, non-porous, non-cemented H1 Hip Resurfacing Arthroplasty. It includes a safety study followed by an efficacy study. Patients will be followed up for 10-years postoperatively. The primary aim is to confirm the safety of the H1 hip resurfacing prosthesis by demonstrating non-inferiority of the H1 device in terms of survivorship. The secondary is to evaluate superiority of the ceramic-on-ceramic H1 hip resurfacing prosthesis compared to Metal-on-Metal (MoM) hip resurfacing in terms of absence of metal ion release.The primary end point is revision for any reason.

Conditions

Hip Osteoarthritis; Hip Necrosis; Hip Dysplasia

Keywords

Hip Resurfacing Arthroplasty; Ceramic; Cementless; H1

Outcome Measures

Primary Outcomes (2)

• Oxford Hip Score

  Hip Specific Patient Reported Outcome Measure (PROM)

  10 years

• EQ-5D Health-Related Quality of Life Questionnaire

  Generic Patient Reported Outcome Measure (PROM)

  10 years

Secondary Outcomes (6)

• Complication Rate

  10 years

• Clinical objective outcome measures

  10 years

• Acetabular Implant orientation

  10 years

• Femoral Implant orientation

  10 years

• Low-dose CT

  Up till 2 years

Study Arms (2)

Cohort 1 - Safety

Cohort 1 will consist of the first 20 participants recruited into the study for H1 Hip Resurfacing Arthroplasty. These patients will receive additional CT scans preoperatively and then post-operatively at these time points: immediately postoperatively (2days), at 6 weeks, 3 months, 6 months, 1 year and 2 years. They will have metal-ion measurements for safety analysis. Blood samples will be taken preoperatively and postoperatively at 3 months, 6 months, 1 year and 2 years. A safety analysis of Cohort 1 will be performed at the 6 week, 3 month and 6 month post-operative stage by independent assessors. Yearly clinical evaluations will be performed until 10 years, and radiographs at 3,5,10 years. If the investigation supports the safety of the implant, the study will proceed with recruitment into Cohort 2.

Device: H1 Hip Resurfacing Arthroplasty

Cohort 2 - Efficacy

Cohort 2 will consist of the remaining target size population of 230 patients for H1 Hip Resurfacing Arthroplasty. They will undergo the same intervention as previously described for Cohort 1, but will not undergo metal-ion testing and reduced frequency CT-scans.

Device: H1 Hip Resurfacing Arthroplasty

Interventions

H1 Hip Resurfacing Arthroplasty DEVICE

A non-porous non-cemented ceramic-on-ceramic hip resurfacing arthroplasty device

Cohort 1 - Safety; Cohort 2 - Efficacy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Indications for use of the H1 HRA in this investigation will be patients with end-stage hip disease who are candidates for primary hip arthroplasty using either a metal-on-metal hip resurfacing or a ceramic-on- ceramic THR. Typically they will be younger (\<70 years) and active males and females with end-stage hip osteoarthritis, avascular necrosis of the femoral head, post-traumatic osteoarthritis or developmental dysplasia of the hip (DDH).

You may qualify if:

• Patient requires primary hip arthroplasty due to degenerative joint disease (primary osteoarthritis, posttraumatic osteoarthritis, avascular necrosis, developmental hip dysplasia)

You may not qualify if:

• Patient is between 18 and 70 years old
• Patient willing to comply with study requirements
• Patient is legally entitled and able to consent, agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the informed consent form approved by the Ethics Committee.
• Patient plans to be available through ten (10) years postoperative follow-up
• Patient is able to understand the native language of the country of the trial centre
• Patient has a BMI greater than 40
• Patient suffers from an active inflammatory joint disorder
• Patient has an active infection or sepsis (treated or untreated)
• Patient has insufficient bone stock at the hip (\>1/3 necrosis of the femoral head) or in general as in severe osteopenia or osteoporosis (Tscore \< -2.5 as measured with BMD)
• At the time of enrolment, patient has one or more of the following arthroplasties that have been
• Implanted less than 6 months before the current hip arthroplasty:
• Contralateral primary total hip arthroplasty or hip resurfacing arthroplasty
• Ipsilateral or contralateral primary total knee or unicondylar knee arthroplasty
• Patient takes medications which potentially affect the bone such as corticosteroids and antimitotic medications.
• Patient has a condition that may interfere with the hip arthroplasty survival or outcome (i.e. Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)

Sponsors & Collaborators

• Embody Orthopaedic Limited: lead
• Imperial College London: collaborator

Study Sites (2)

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Kind Edward VII's Hospital

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

5 samples of 2ml of Blood stored in EDTA tubes will be taken and analysed for metal ion levels

MeSH Terms

Conditions

Osteoarthritis, Hip; Hip Dislocation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Joint Dislocations; Wounds and Injuries; Hip Injuries

Study Officials

• Justin P Cobb, FRCS

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2017
• First Posted: October 31, 2017
• Study Start: September 26, 2017
• Primary Completion (Estimated): September 25, 2032
• Study Completion (Estimated): March 25, 2033
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)