Clinical Study With the seleXys PC and the RM Pressfit Vitamys Cup

University Hospital Basel

Status: Active, not recruiting

Conditions: Hip Joint; Arthritis, Degenerative

Treatments: Device: seleXys PC; Device: RM

Study type: Interventional

Funder types: Other

Identifiers

NCT03260465

2017-00832 mu21Stoffel;

Details and patient eligibility

About

This is a randomized controlled trial with the seleXys PC cup and RM Pressfit vitamys cup in combination with the optimys short stem. Wear rate and migration is assessed with roentgen stereophotogrammetric analysis (RSA) measurements.

Enrollment: 53 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with symptomatic arthritis who are candidates for a primary total hip arthroplasty with an uncemented femoral stem as determined jointly by the surgeon and the patient.
• Patients suitable for an uncemented acetabular component in combination with a 36mm femoral head (seleXys PC cup: 52mm, 54mm or 56mm; RM Pressfit vitamys: 52mm, 54mm or 56mm)
• Patients between the ages of 50 and 75 inclusive
• Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up

Exclusion criteria

• Patients that require an acetabular cup size which cannot be used in combination with a 36mm femoral head
• Patients that offer no guarantee for regular follow-up controls
• Patients that have a revision surgery
• Patients that have a fracture of the femoral neck or a bone tumour in the area of the femur or pelvis
• Patients that had a previous osteotomy of the femur or pelvis
• Pregnant women or those seeking to become pregnant
• Patients with a history of active infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

seleXys PC

Experimental group

Description:

seleXys PC cup combined with the optimys stem

Treatment:

Device: seleXys PC

RM

Active Comparator group

Description:

RM Pressfit vitamys cup combined with the optimys stem

Treatment:

Device: RM