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A clinical RSA study using the Symax stem

A clinical RSA study using the Symax stem - RSA Symax hip

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30594
Enrollment
26
Registered
2008-01-18
Start date
2007-10-01
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

hip osteoarthritis hip prosthesis

Interventions

The study population will get a cementless RSA Symax hip arthroplasty. To do the symax measurements correctly a number of tantallum markers will be inserted into the femur during surgery. This will

Sponsors

Stryker Howmedica
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: age between 18 and 70 years Patients requiring uncemented primary THA Patients with a diagnosis of osteoarthritis, rheumatoid arthritis, avascular necrosis or post-traumatic arthritis

Exclusion criteria

Exclusion criteria: patients who require a revision of previous implanted THA Patients with BMI>35 Patients who have had a prior procedure of femoral osteotomy patients with active or suspected infection patients with malignancy

Design outcomes

Primary

MeasureTime frame
The primary study objective is to determine the prosthetic migration of the Symax stem in the first two years after implantation

Secondary

MeasureTime frame
Secundary objectives are the clinical outcome of these patients and the patient satisfaction. And also the assessment of the precision of RSA measurements in this hospital.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)