Plain English Summary
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 September 2022
Who is funding the study?
MatOrtho Limited (UK)
Who is the main contact?
Dr Laura Richards
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MOP002
Study information
Scientific title
Prospective randomised controlled study: Adept and Conserve Plus Hip Resurfacing Devices
Acronym
Study hypothesis
Null hypothesis:
There will be no difference between the devices as this is a non-inferiority study.
Ethics approval
Jewish General Hospital Canada, 05/04/2016, ref: 15-174
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format
Condition
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
Phase
Drug names
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 trial start date
01/03/2012
Overall trial end date
01/09/2022
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
46
Participant 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
Recruitment start date
01/03/2017
Recruitment end date
01/12/2019
Locations
Countries of recruitment
Canada
Trial participating centre
Jewish General Hospital
3755 Chemin de la Côte-Sainte-Catherine
Montreal
H3T 1E2
Canada
Trial participating centre
Ottawa Hospital
501 Smyth Rd
Ottawa
K1H 8L6
Canada
Sponsor information
Organisation
MatOrtho Limited
Sponsor details
13 Mole Business Park
Randalls Road
Leatherhead
KT22 7BA
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
MatOrtho Limited
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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.
Intention to publish date
01/09/2021
Participant level data
Not expected to be available
Basic results (scientific)
Publication list