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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

Completed
Conditions
disabled hip
osteoarthritis
10005944
Registration Number
NL-OMON39428
Lead Sponsor
Reinier de Graaf Groep
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
45
Inclusion Criteria

1. Male and non pregnant female patients between 18-65 years of age.
2. Patients with a quetelet index (QI<=weight in (kilogram)/ squire length (meters)) < 35
3. Patients requiring uncemented primary THR, suitable for the use of the Mallory Head stem
4. The individual has no clinical relevant contra indications for total hip replacement
5. The patient is diagnosed with osteoarthritis (OA) or avascular necrosis
6. The individual is physically and mentally willing and able to comply with postoperative functional evaluation and able to participate in an appropriate rehabilitation schedule.
7. Patients who signed the Ethics Committee approved specific Informed Consent Form prior to surgery

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).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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