Randomised study comparing the metal ions released from two different hip resurfacing devices
| ISRCTN | ISRCTN82045842 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82045842 |
| Secondary identifying numbers | MOP002 |
- Submission date
- 17/02/2017
- Registration date
- 02/03/2017
- Last edited
- 15/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteoarthritis of the hip is a common condition that develops with advancing age. It is usually caused by the wear and tear of the cartilage that lines the hip joint, causing bones to rub against each other. This results in pain, stiffness and a loss in mobility. When pain becomes uncontrollable, hip replacement surgery is often performed. Hip replacement surgeries are one of the most common surgeries in the world and have a high success rate. Surgeons and orthopaedic companies have developed a number of hip surgery innovations that are less intensive including resurfacing systems. Hip resurfacing is a bone conserving surgical procedure where instead of completely removing a part of the hip, the bone is capped with a smooth metal covering. The damaged bone and cartilage is removed and replaced with a metal shell, just as in a traditional hip replacement. Hip resurfacing can allow for patients to pursue physical activities such as running, jumping, and playing sports that are discouraged after a total hip replacement. There are many types of resurfacing devices that are available to surgeons. The Adept Hip resurfacing system has been successfully used in the UK, Europe, Australia and New Zealand and has one of the lowest revision (failure) rates of all hip resurfacing. However, in Canada this procedure has not yet been approved. This study aims to compare the Adept to the current hip resurfacing device used in Canada, the Conserve Plus hip resurfacing device, by measuring the amount of metal ions present in the blood and by following patient progress after surgery.
Who can participate?
Adults between the ages of 18 and 60 who require a hip replacement.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the standard hip resurfacing device, the Conserve Plus which comes in sizes of 36 mm to 54 mm. Those in the second group receive the Adept device, which is similar to the Conserve plus device but comes in different sizes (48 mm to 58 mm), has a different maker, and has not yet been approved in Canada (but has ten years of clinical history). Participants then undergo the standard hip resurfacing surgery. Blood samples are taken before samples and at one and two years after surgery. Participants are followed up one and two years after the surgery to measure how well the hip resurfacing worked.
What are the possible benefits and risks of participating?
There are no notable benefits or risks involved with participating.
Where is the study run from?
1. Jewish General Hospital (Canada)
2. Ottawa Hospital (Canada)
When is the study starting and how long is it expected to run for?
March 2012 to June 2026
Who is funding the study?
MatOrtho Limited (UK)
Who is the main contact?
Dr Laura Richards
Contact information
Public
13 Mole Business Park
Randalls Road
Leatherhead
KT22 7BA
United Kingdom
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format |
| Scientific title | Prospective randomised controlled study: Adept and Conserve Plus Hip Resurfacing Devices |
| Study objectives | Null hypothesis: There will be no difference between the devices as this is a non-inferiority study. |
| Ethics approval(s) | Jewish General Hospital Canada, 05/04/2016, ref: 15-174 |
| Health condition(s) or problem(s) studied | Osteoarthritis |
| Intervention | Participants are randomly allocated to either intervention or control group. Both groups undergo hip resurfacing which is a surgical procedure that involves placing a metal device or cap on the head of the femur. The surgery is done to the standard level of care. Control group: Participants in this group receive the Conserve plus hip resurfacing system as it is the standard hip resurfacing system used in Canada and is the current standard of care. The Conserve device is composed of cobalt chromium metal and comes in head sizes 36 mm to 54 mm. Intervention group: Participants in this group receive the Adept hip resurfacing device which is a different device type that is used for the hip resurfacing. Adept hip resurfacing has 13 years clinical history, is CE marked and TGA approved but is not available in Canada. Participants undergo the surgical procedure as per the current standard of care. The Adept device is composed of cobalt chromium metal and is available in head sizes 48 mm to 58 mm. The stem on the femoral component of this device is different to the device in the control control group and the instrumentation varies between the devices as they have different manufacturers. The participants are followed up one and two years post operative. Participants are required to have blood samples taken both pre operative and post operative and are asked to complete questionnaires at the post-operative appointments. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Blood metal ions (cobalt and chromium) are measured using blood samples at baseline, one and two years post operative. |
| Secondary outcome measures | 1. Pain, function and range of motion in patients are assessed using the Harris Hip Score at baseline, one and two years post-operative 2. Activity level is measured using the UCLA Activity Score at baseline, one and two years post-operative 3. Surgical outcomes are measured by clinical assessments using a scoring system at one and two years post-operative 3.1. Surgical outcomes are measured by radiographs at baseline, six weeks, one year and two years post-operative |
| Overall study start date | 01/03/2012 |
| Completion date | 01/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 46 |
| Key inclusion criteria | 1. Requires primary hip arthroplasties 2. Between the age of 18 and 60 years at time of surgery 3. Good femoral bone stock as determined by the surgeon 4. Understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up 5. Capable of, and have given, informed consent to their participation in the study |
| Key exclusion criteria | 1. Previous metal work in situ 2. Previous femoral or pelvic osteotomy 3. Dysplasia of the hip requiring structural graft 4. Osteopenia or osteoporosis 5. Hepatic or renal insufficiency 6. Contralateral total or resurfacing hip prosthesis, or patients requiring bilateral hip replacement 7. Planning to become, or who are, pregnant |
| Date of first enrolment | 01/03/2017 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- Canada
Study participating centres
Montreal
H3T 1E2
Canada
Ottawa
K1H 8L6
Canada
Sponsor information
Industry
13 Mole Business Park
Randalls Road
Leatherhead
KT22 7BA
United Kingdom
| Website | www.matortho.com |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/01/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The data will be held by the company/sponsor MatOrtho and by the hospitals participating in the study. MatOrtho makes data available through peer-reviewed publications which can be adequately referenced. |
Editorial Notes
15/12/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2022 to 31/12/2023.
2. The overall end date was changed from 01/06/2025 to 01/06/2026.
3. The intention to publish date was changed from 01/06/2026 to 01/01/2027.
4. The plain English summary was updated to reflect these changes.
08/06/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/06/2021 to 31/12/2022.
2. The overall end date was changed from 01/09/2022 to 01/06/2025.
3. The intention to publish date was changed from 01/09/2021 to 01/06/2026.
4. The plain English summary was updated to reflect these changes.
15/01/2020: The recruitment end date has been changed from 01/12/2019 to 01/06/2021.
