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OpenTrials
Completed

NCT Number: NCT04599582

Prospective Randomised Study of a New an Uncemented Stem.

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.

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hip arthroplasty

Device

Patients are operated with hip replacement.

Primary outcomes

  1. Oxford hip score

    Time frame: two years

    Patient reported outcome measure

Secondary outcomes

  1. RSA-examination

    Time frame: two years

    Migration of stem

  2. Conventional X-rays

    Time frame: two years

    Detection of radiolucent lines

  3. Harris hip score

    Time frame: two years

    Patient reported outcome

  4. DXA

    Time frame: Two years

    Change of bone mineral density

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Link America, Inc.

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 22, 2020
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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