Comparative roentgen stereophotogrammetry analysis of the Global Tissue Sparing (GTS) stem ® compared with uncemented HA coated Taperloc stem.

Comparative roentgen stereophotogrammetry analysis of the Global Tissue Sparing (GTS) stem ® compared with uncemented HA coated Taperloc stem. - RSA analysis of GTS vs Taperloc stem

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55416

Enrollment

Registered

2012-11-26

Start date

2013-01-21

Completion date

Unknown

Last updated

2024-11-18

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

Conditions

joint wear osteoarthrosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Male and non-pregnant females :

Exclusion criteria

Exclusion criteria: - Patients who had a THA on contralateral side more than 6 months ago and the rehabilitation period outcome is 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). - Patients who had a THA on contralateral side less than 6 months ago. - Patients with a major surgical procedure during the 12 weeks before the study-related operation. - Dutch language not mastered - The patient is unwilling to cooperate with the study

Design outcomes

Primary

Measure	Time frame
The primary outcome is stem migration at 2 years postoperatively measured with RSA analysis.	—

Secondary

Measure	Time frame
Outcome will be clinically measured using the Harris Hip Score (HHS), HOOS (WOMAC) questionnaire, EQ5-D, 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.	—

Countries

Netherlands

Outcome results