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Dr Study Contact
+44 (0)1372 224 200
info@matortho.com


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Be Part of Research - Trial Details - Patient reported clinical outcomes and imaging study for a new all-ceramic hip resurfacing device
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Patient reported clinical outcomes and imaging study for a new all-ceramic hip resurfacing device

Recruiting

Open to: All Genders

Age: Adult

Newcastle

Medical Conditions

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

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

30 Jun 2020 31 Mar 2025

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.


Adults eligible for hip resurfacing.

You can take part if:



You may not be able to take part if:


1. Patient deemed unsuitable for hip resurfacing arthroplasty by the surgeon2. Patient has significant contraindications when following the manufacturer's Instruction For Use of the product3. Patient likely to become incapacitated during the study4. 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


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Freeman Hospital
    James Holland Newcastle Upon Tyne Hospital Trust Freeman Road High Heaton
    Newcastle
    NE7 7DN

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.

Dr Study Contact
+44 (0)1372 224 200
info@matortho.com



The study is sponsored by MatOrtho Limited and funded by MatOrtho Limited.




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Read full details for Trial ID: ISRCTN93110271
Last updated 12 December 2024

This page is to help you find out about a research study and if you may be able to take part

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