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Comparative roentgen stereophotogrammetry analysis (RSA) between the conventional Mallory- Head stem in primary uncemented total hip replacement compared to two shorter variations

Comparative roentgen stereophotogrammetry analysis (RSA) between the conventional Mallory- Head stem in primary uncemented total hip replacement compared to two shorter variations - RSA short Mallory-head total hip prosthesis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39428
Enrollment
45
Registered
2007-05-16
Start date
2008-01-16
Completion date
Unknown
Last updated
2024-06-18

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

Conditions

disabled hip osteoarthritis

Interventions

Intervention: Placement of an uncemented primary Mallory-Head® cup in combination with either the Mallory-Head short stems or the conventional Mallory-Head stem for primary uncemented THA.

Sponsors

Reinier de Graaf Groep
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Male and non pregnant female patients between 18-65 years of age. 2. Patients with a quetelet index (QI

Exclusion criteria

Exclusion criteria: 1. The patient is unwilling to cooperate with the study 2. The patient has disorders clinically relevant for total hip replacement 3. The patient is pregnant or desired to be pregnant after surgery or is using inadequate birth control 4. Patients who had or will need another joint replacement within six months. 5. Patients who had a THA on contralateral side more than 6 months ago and the rehabilitation period outcome was considered unsatisfactory or not good. (Patients with contra-lateral THA >6 months ago with good outcome (Harris Hip Score >85) can be included in the study).

Design outcomes

Primary

MeasureTime frame
Main study parameters/endpoints: Outcome will be clinically measured using the Harris Hip Score (HHS), HOOS / WOMAC questionnaire, SF-12, (whilst radiographic outcomes will be evaluated through standard radiographic parameters which include qualitative femoral and acetabular findings as well as position of the stem and cup. RSA will be used to measure stem migration.

Secondary

MeasureTime frame
n.a.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)