Condition category
Musculoskeletal Diseases
Date applied
17/02/2017
Date assigned
02/03/2017
Last edited
01/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Public

Primary contact

Dr Laura Richards

ORCID ID

Contact details

13 Mole Business Park
Randalls Road
Leatherhead
KT22 7BA
United Kingdom

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 measures

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

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

www.matortho.com

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes