Skip to content

Prospective Randomised Study of a New an Uncemented Stem.

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04599582
Enrollment
80
Registered
2020-10-22
Start date
2016-04-01
Completion date
2019-05-31
Last updated
2020-10-22

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

Conditions

Hip Osteoarthritis

Keywords

hip arthroplasty, Joint replacement, Uncemented stem, Anatomical stem

Brief 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.

Interventions

DEVICEHip Arthroplasty

Patients are operated with hip replacement.

Sponsors

Link America, Inc.
CollaboratorINDUSTRY
Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Oxford hip scoretwo yearsPatient reported outcome measure

Secondary

MeasureTime frameDescription
RSA-examinationtwo yearsMigration of stem
Conventional X-raystwo yearsDetection of radiolucent lines
Harris hip scoretwo yearsPatient reported outcome
DXATwo yearsChange of bone mineral density

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026