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The effect of Refobacin and Palacos bone cement on fixation of total hip prosthesis (THP): A clinical RSA-study on a force enclosed stem.

The effect of Refobacin and Palacos bone cement on fixation of total hip prosthesis (THP): A clinical RSA-study on a force enclosed stem. - Effect of 2 bone cements on fixation of THP

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON30670
Enrollment
50
Registered
2007-05-14
Start date
2007-03-01
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

Prosthesis fixation / loosening

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with primary and secondary osteoarthritis who need a total hip prosthesis; Patients capable of giving informed consent and expressing a willingness to comply with the post-operative review program

Exclusion criteria

Exclusion criteria: Patients requiring revision arthroplasty; Patients with primairy bone disease The patient is unable or unwilling to sign the Patient Informed Consent (PIC) specific to this study

Design outcomes

Primary

MeasureTime frame
Pre-treatment evaluation will consist of clinical assessment, and medical history, functional evaluation (using different score forms) and by radiographic evaluation. After surgery evaluation will be performed on different intervals using measurements of RSA and functional evaluation (e.g. pain, work/activity level).

Secondary

MeasureTime frame
None

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)