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

ReCerf Hip Resurfacing Clinical Investigation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN93110271
Enrollment
78
Registered
2020-10-15
Start date
2020-06-30
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Sponsors

MatOrtho Limited
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

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 years

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

England, Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 23, 2026