Prospective Randomised Study of a New an Uncemented Stem.

Sahlgrenska University Hospital

Status: Completed

Conditions: Hip Osteoarthritis

Treatments: Device: Hip Arthroplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04599582

Kärrholm: SPCL study

Details and patient eligibility

About

Patients will be randomised to either operation with a Corail stem or a SP-CL stem. The groups are examined with RSA, conventional x-rays, PROM-data and DXA. First evaluation will be done at two years.

Enrollment: 80 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary osteoartritis Secondary osteoartritis

Exclusion criteria

• Ongoing treatment with corticoid steroids, Active cancer disease, previously known osteoporosis or osteomalacia, inflammatory arthritis, unsuitable anatomy, difficulties to speak or understand the Swedish language.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

SP-CL

Active Comparator group

Treatment:

Device: Hip Arthroplasty

Corail

Active Comparator group

Treatment:

Device: Hip Arthroplasty