Patient reported clinical outcomes and imaging study for a new all-ceramic hip resurfacing device

Plain English Summary

Background and study aims
Hip replacement is a successful medical intervention that treats diseased or damaged joints. There are two options for hip replacement implants and this is total hip replacement or hip resurfacing replacement. A total hip replacement removes the entire head of the bone for replacement whereas hip resurfacing as it suggests removes just the damaged surface of the joint. Hip resurfacing is therefore a more bone conserving operation and may offer benefits to younger/active patients.

Currently hip resurfacing is manufactured using all-metal (cobalt chromium). A small proportion of patients can have an adverse reaction to metal debris leading to early failure of the implant. Therefore more benign materials such as ceramics commonly used in total hip replacement are of interest and BIOLOX® delta ceramic (CeramTec) has clinical use. MatOrtho's ReCerf is an all-ceramic hip resurfacing device manufactured from this clinically successful BIOLOX® delta ceramic. The aim of this study is to demonstrate the performance of ReCerf Hip Resurfacing is comparable to clinical data from existing hip implants and this data will support regulatory applications in the future.

Who can participate?
Adults eligible for hip resurfacing.

What does the study involve?
All patients would complete questionnaires about their hip before surgery and then at 6, 12 and 24 months post-surgery. Adverse events and revision would be reported over 24 months. Standard radiographs would be collected. Patients recruited at Oxford would be assessed by RSA after surgery (within 5 days) and at 6, 12 and 24 months post-surgery.

What are the possible benefits and risks of participating?
Benefits:
The information collected in this programme will be used to increase medical community knowledge on Hip Resurfacing implants. This could influence future thinking on the best treatment routes. The Hip Resurfacing itself should provide the patient with relief from their symptoms. Collecting data does not intervene in any way with the patients normal treatment and rehabilitation programme.

Risks:
There are general risks of surgery and receiving a hip implant. There are risks to receiving a new device. The clinical performance and longevity of the ReCerf device are not proven and residual risks are possible. Unknown or unexpected failure modes can occur for new devices.
X-rays used to assess the positioning of a hip replacement expose you to a small amount of radiation.
Patients taking part in RSA migration study will have very small tantalum beads placed in the bone near to the Investigational Device. The insertion of beads takes an additional 5 to 10 minutes during surgery. Although this increases surgical time, there is no increase incidence of infection, bleeding, or blood clotting. The beads get stably integrated into the bone, however, the beads could move or become loose, eventually embedding in adjacent tissue. This risk is considered very small; over 300,000 beads have been implanted worldwide with no adverse effects related to bead movement or loosening.

Where is the study run from?
MatOrtho Limited (UK) and hospitals in the UK

When is the study starting and how long is it expected to run for?
June 2019 to June 2023

Who is funding the study?
MatOrtho Limited (UK)

Who is the main contact?
Dr Laura Richards, laura.richards@matortho.com

Trial website

Type

Scientific

Primary contact

Dr Laura Richards

ORCID ID

Contact details

19/20 Mole Business Park
Randalls Road
Leatherhead
KT22 7BA
United Kingdom
+44 (0)7787403972
laura.richards@matortho.com

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

ST-010320-CI, IRAS 277975

Scientific title

ReCerf Hip Resurfacing Clinical Investigation

Acronym

Study hypothesis

There are two hypotheses: The clinical trial will assess that the amount of migration of components over time as compared to the surrounding bone (reference) is acceptable; and patient reported outcome using an Oxford Hip Score questionnaire will not be worse than the National average reported in the UK National Joint Registry for similar devices.

Ethics approval

Approved 02/04/2020, London-Stanmore Research Ethics Committee (Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0)20 7972 2561, stanmore.rec@hra.nhs.uk), ref: 20/LO/0279

Study design

Prospective obervational non randomised multicentre

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

End-stage joint disease e.g. osteoarthritis, requiring hip joint replacement

Intervention

All patients taking part in the study would receive a Patient Information Sheet from their consultant if they are eligible for hip resurfacing. Following consent the patient would be asked to answer a series of questionnaires on their hip (baseline, pre-op data). Information on pre-op health and demographics would be recorded prior to surgery. The data collected would not include personal information and would not identify the patient. The patient would only be identified with the study ID number throughout. Intra-operatively, surgical details would be collected including component details. Post-operatively patients would complete questionnaires at 6, 12 and 24 months. Standard radiographs would be taken and collected for the study. Throughout, adverse events including readmissions and revisions would be collected.

In addition, patients recruited at Oxford would be invited to take part in a migration (‘RSA’) study. The patients would complete all of the same methods above but would also have RSA imaging. RSA stands for radiostereometric analysis and it is a highly accurate method to measure small movements over time between the implant components and the bone. RSA uses a dual set of stereo x-rays. The RSA assessment is taken immediately post-surgery (within 5 days) and at 6, 12 and 24 months.

The total duration of follow-up for all patients is 24 months post-surgery. The observations will take around 20-30 minutes for patient reported scores. The RSA assessment would take 40-60 minutes.

Intervention type

Device

Phase

Not Specified

Drug names

ReCerf Hip Resurfacing

Primary outcome measure

1. Proximal migration measured by RSA at 12 months
2. Hip function measured using the Oxford Hip Score at 6 months

Secondary outcome measures

1. Migration measured by RSA at 6 and 24 months
2. Hip function measured using the Oxford Hip Score at 12 and 24 months
3. Rate of adverse events collected by research team as they occur (all times to 24 month)
4. Revision rate (i.e device failure rate) measured by research team as they occur (all times to 24 month)
5. Additional PROMs (pre-op, 6, 12 and 24 months):
5.1. Hip function (Oxford Hip Score)
5.2. Quality of life (EQ5D)
5.3. Hip symptoms (HOOS)
5.4. Activity (UCLA Activity Scale)
5.5. Satisfaction score (using a novel 4 item questionnaire)
5.6. Single question on joint awareness

Overall trial start date

06/06/2019

Overall trial end date

01/06/2023

Reason abandoned (if study stopped)

Participant inclusion criteria

1. Patient suitable for hip resurfacing arthroplasty
2. Patient able to give informed consent
3. Patient willing and able to take part in the study for the prescribed length of the study
4. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
5. Minimum age of 18

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

78

Participant exclusion criteria

1. Patient deemed unsuitable for hip resurfacing arthroplasty by the surgeon
2. Patient has significant contraindications when following the manufacturer's Instruction For Use of the product
3. Patient likely to become incapacitated during the study
4. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study

Recruitment start date

30/06/2020

Recruitment end date

30/01/2021

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham University Hospital Trust
Hucknall Road Nottingham NG5 1PB
Nottingham
NG5 1PB
United Kingdom

Trial participating centre

Freeman Hospital
Newcastle Upon Tyne Hospital Trust Freeman Road High Heaton Newcastle upon Tyne
Newcastle
NE7 7DN
United Kingdom

Trial participating centre

Southmead Hospital
Bristol North Trust Hospital Southmead Road Westbury-on-Trym Bristol
Bristol
BS10 5NB
United Kingdom

Trial participating centre

Warwick Hospital
Warwick Hospital Trust Lakin Road
Warwick
CV34 5BW
United Kingdom

Trial participating centre

Princess Grace Hospital
42-52 Nottingham Pl Marylebone
London
W1U 5NY
United Kingdom

Trial participating centre

NHS Greater Glasgow and Clyde Trust
1055 Great Western Rd
Glasgow
G12 0XH
United Kingdom

Trial participating centre

Oxford University Hospitals
Windmill Road Headington
Oxford
OX3 7HE
United Kingdom

Organisation

MatOrtho Limited

Sponsor details

19/20 Mole Business Park
Randalls Road
Leatherhead
KT22 7BA
United Kingdom
+44 (0)1372 224 200
info@matortho.com

Sponsor type

Industry

Website

https://www.matortho.com/

Funder type

Industry

Funder name

MatOrtho Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Publication and dissemination plan

Planned publication in high impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

30/06/2023

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

09/10/2020: Trial’s existence confirmed by the MHRA.