To evaluate the clinical outcome of a ceramic-on-ceramic hip resurfacing arthroplasty using the ceramic, non-porous, non-cemented H1 Hip Resurfacing Arthroplasty
| ISRCTN | ISRCTN91554748 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91554748 |
| IRAS number | 213102 |
| ClinicalTrials.gov number | NCT03326804 |
| Secondary identifying numbers | IRAS 213102 |
- Submission date
- 30/11/2020
- Registration date
- 09/12/2020
- Last edited
- 29/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English Summary
Background and study aims
Hip surgery to restore function (hip arthroplasty) is usually necessary when the hip joint is worn or damaged so that mobility is reduced and the person is in pain even while resting. The most common reason for hip replacement surgery is osteoarthritis. Other conditions that can cause hip joint damage include rheumatoid arthritis, hip fracture, septic arthritis, disorders that cause unusual bone growth (bone dysplasia).
Hip resurfacing provides a new surface for the ball and socket that make up the hip joint. Unlike a total hip replacement, it retains more of the bone. During the procedure, the damaged surfaces of the femur head (ball of the thighbone) and the acetabulum (socket in the pelvis) are reshaped and replaced with a cover.
The aim of the H1 study is to assess the short, mid and long-term safety and function of the new H1 Hip Resurfacing implant. Resurfacing, rather than replacing, the hip has long been a desirable option, but owing to limitations in materials and design, most resurfacing products have now been withdrawn from the market. The H1 System represents the next generation of hip resurfacings, with superior design and material characteristics.
Who can participate?
Patients aged between 18 and 70 years who require primary hip arthroplasty due to degenerative joint disease and meet the study inclusion criteria.
What does the study involve?
Participants will receive treatment as usual, however they will need to attend more follow up visits in order to provide data for the study over the following 10 years.
What are the possible benefits and risks of participating?
Benefits: The H1 Hip resurfacing implant is designed to address the symptoms associated with a degenerated hip. In addition, to eliminating pain and restoring mobility, receiving this implant may reduce the amount of bone that must be removed. Participants will also be closely monitored for 10 Years. The device has not been studied clinically and so benefit is not assured. There are no other clear benefits to the participant from taking part. However, the information we get from this research might help in the future with management of joint disease.
Risks: Any operation to replace or resurface the hip carries risks, so the decision to proceed with a hip arthroplasty of any sort needs to be taken with caution. The potential benefit of a pain free hip has to be balanced with the risks of the operation causing an unexpected problem of some sort.
Where is the study run from?
Imperial College London (UK)
When is the study starting and how long is it expected to run for?
September 2017 to September 2032
Who is funding the study?
Embody Orthopaedic Limited (UK)
Who is the main contact?
Dr Mariam Al-Laith, m.al-laith@imperial.ac.uk
Contact information
Scientific
MSk Lab 2nd Floor, Room 201
Sir Michael Uren Hub
Imperial College London
White City Campus
86 Wood Lane
London
W12 0BZ
United Kingdom
 ORCID ID |
0000-0001-6043-2006 |
|---|---|
| Phone | +44 (0)207 5942697 |
| m.al-laith@imperial.ac.uk |
Study information
| Study design | Multi-centre prospective non-randomised observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN91554748_PIS_v2_05Oct2020.pdf |
| Scientific title | H1 Hip Resurfacing Arthroplasty |
| Study hypothesis | The primary hypothesis of the study is that the H1 implant will demonstrate non-inferiority in terms of survivorship compared to the Birmingham Hip Replacement. The secondary hypothesis is that the H1 implant will be demonstrated to be superior in terms of toxicology compared to the Birmingham Hip Replacement |
| Ethics approval(s) | Approved 12/09/2017, East of England – Cambridge Central Research Ethics Committee (Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8388; cambridgecentral.rec@hra.nhs.uk), ref: 17/EE/0330 |
| Condition | Hip arthroplasty |
| Intervention | Patients partaking in this investigation shall undergo hip surgery to have an H1 hip resurfacing implanted. A smaller cohort of patients shall additionally have small beads inserted into the bone surrounding the implant during the hip surgery, which will allow closer post-operative monitoring of the implant. As part of this study, for the main cohort of patients, the following events will take place in addition to the standard of care which would be received. 1. Demographic information and medical history will be recorded before surgery 2. X-rays of the hip will be taken post-operatively at 1 year, 2 years, 3 years, 5 years and 10 years. 3. Pre-operatively, and post-operatively at 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years, participants will be asked to complete questionnaires (EQ5D, Oxford Hip Score and Imperial Score) to evaluate hip function (these can be complete onsite or at participants own convenience). In addition, participants will be asked to complete a paper-based questionnaire (Harris Hip Score). 4. All participants will be followed up for 10 years and a final evaluation will occur at the end of the 10-year follow-up visit For a smaller cohort of patients, the following events will take place in addition to the standard of care which would be received. 1. Demographic information and medical history will be recorded before surgery 2. CT scans of the hip will be performed post-operatively, at 2 days, 6 weeks, 3 months, 6 months, 9 months, 1 year and 2 years. The CT scan at 6 weeks will replace the X-ray that would normally have been given in routine care. 3. X-rays of the hip will be taken post-operatively 3 years, 5 years and 10 years. 4. Pre-operatively, and post-operatively at 6 weeks, 3 months, 6 months, 9 months, and annually up to 10 years, participants will be asked to complete questionnaires (EQ5D, Oxford Hip Score and Imperial Score) to evaluate hip function (these can be complete onsite or at participants own convenience). In addition, participants will be asked to complete a paper-based questionnaire (Harris Hip Score). 5. All participants will be followed up for 10 years and a final evaluation will occur at the end of the 10-year follow-up visit |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | H1 Hip Resurfacing Arthroplasty |
| Primary outcome measure | 1. The efficacy of the implant shall be measured by Implant survivorship (defined as 98.6% cumulative survivorship without revision for any reason at 1 year, 97.6% survivorship at 3 years, 96.5% survivorship at 5 years and 93% survivorship at 10 years) At 6 weeks, 6 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years: 2. Hip function will be measured by the Oxford Hip Score and the Imperial Hip Score 3. Quality of life shall be measured by the EQ5D score 4. Mobility and hip function shall be measured by the Harris Hip Score 5. Implant orientation and stability shall be measured by X-rays |
| Secondary outcome measures | 1. Safety of the implant shall be measured by the number of adverse events and revisions throughout the study taken from patient records 2. Safety of the implant in terms of toxicology shall be measured by blood metal ion levels and compared to MHRA action levels using blood tests (when taken) at 3, 6, 12 and 24 months 3. Implant stability in terms of migration shall be measured by CT assessment at 6 weeks, 3, 6, 9, 12 and 24 months |
| Overall study start date | 12/09/2017 |
| Overall study end date | 26/09/2032 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 250 |
| Participant inclusion criteria | 1. Patient requires primary hip arthroplasty due to degenerative joint disease (primary osteoarthritis, posttraumatic osteoarthritis, avascular necrosis, developmental hip dysplasia) 2. Patients femoral bone stock is adequate for hip resurfacing on plain radiographs 3. Patient is between 18 and 70 years old 4. Patient willing to comply with study requirements 5. Patient plans to be available through 10 years postoperative follow-up 6. Patient is able to understand the native language of the country where their procedure is taking place. |
| Participant exclusion criteria | 1. Patient has a BMI greater than 40 kg/m² 2. Patient suffers from an active inflammatory joint disorder 3. Patient has an active infection or sepsis (treated or untreated) 4. Patient has insufficient bone stock at the hip (>1/3 necrosis of the femoral head) 5. Patient has severe osteopenia or osteoporosis, defined using DXA by T-score of <-2.5 (if T-score does not meet the criteria, please confirm with coordinating site (ICL) for participant eligibility) 6. Patient has large and multiple cysts in the femoral head (patients with cysts to be reviewed by coordinating site (ICL) for participant eligibility) 7. 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: 7.1. Contralateral primary total hip arthroplasty or hip resurfacing arthroplasty 7.2. Ipsilateral or contralateral primary total knee or unicondylar knee arthroplasty 8. Patient takes medications which potentially affect the bone such as corticosteroids and antimitotic medications 9. 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) 10. Patient has a known alcohol or drug abuse 11. Patient has an immunosuppressive disorder 12. Patient has a malignant tumour, metastatic, or neoplastic disease 13. Patient has severe comorbidities or a limited life expectancy 14. Patient lacks capacity to consent 15. Patient has an emotional or neurological condition that would pre-empt his/her ability or willingness to participate in the study 16. Patient is not willing or able to sign an informed consent form 17. Patient pregnant or breast feeding 18. Patient is not able or willing to come to follow-up visits 19. Any other clinical reason, which the investigator considers would make the patient unsuitable for the trial 20. Implant size unavailable |
| Recruitment start date | 26/09/2017 |
| Recruitment end date | 31/03/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
W6 8RF
United Kingdom
London
W1G 6AA
United Kingdom
Epsom
KT18 7EG
United Kingdom
Truro
TR1 3LJ
United Kingdom
Bloomsbury
London
NW1 2BU
United Kingdom
Sponsor information
Industry
Sir Michael Uren Hub
86 Wood Lane
London
W12 0BZ
United Kingdom
| Phone | +44 (0)207 5943600 |
|---|---|
| susannah.clarke@embody-ortho.com | |
| Website | https://embody-ortho.com/ |
"ROR" |
https://ror.org/018caxa54 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 26/03/2033 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact and peer reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v2 | 05/10/2020 | 04/01/2021 | No | Yes |
| Protocol file | version v8 | 02/10/2020 | 04/01/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN91554748_PIS_v2_05Oct2020.pdf
- Uploaded 04/01/2021
- ISRCTN91554748_PROTOCOL_v8_02Oct2020.pdf
- Uploaded 04/01/2021
Editorial Notes
29/12/2021: The recruitment end date has been changed from 26/09/2022 to 31/03/2022.
04/01/2021: Uploaded protocol Version 8, 2 October 2020 (not peer reviewed). The participant information sheet has been uploaded.
04/12/2020: Trial’s existence confirmed by East of England – Cambridge Central Research Ethics Committee.
