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Randomised study comparing the metal ions released from two different hip resurfacing devices

Prospective randomised controlled study: Adept and Conserve Plus Hip Resurfacing Devices

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN82045842
Enrollment
46
Registered
2017-03-02
Start date
2016-11-21
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Osteoarthritis Musculoskeletal Diseases Osteoarthritis

Interventions

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 o

Sponsors

MatOrtho Limited
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Blood metal ions (cobalt and chromium) are measured using blood samples at baseline, one and two years post operative.

Secondary

MeasureTime frame
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

Countries

Canada

Contacts

Public ContactLaura Richards

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026