Prospective Randomised Study of a New an Uncemented Stem.

Hip Osteoarthritis Clinical Trial

Official title:

Prospective Randomised Study of a New Anteverted Uncemented Stem. Randomised Study Between the SP-CL and the Corail Stem With the Use of a Delta Cup.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04599582
• Other study ID #: Kärrholm: SPCL study
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: May 31, 2019

Study information

• Verified date: October 2020
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• Hip Arthroplasty
Patients are operated with hip replacement.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Link America, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford hip score	Patient reported outcome measure	two years
Secondary	RSA-examination	Migration of stem	two years
Secondary	Conventional X-rays	Detection of radiolucent lines	two years
Secondary	Harris hip score	Patient reported outcome	two years
Secondary	DXA	Change of bone mineral density	Two years