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Active, Not Recruiting

NCT Number: NCT03279276

Selecting the Right Hip Prosthesis for Young Patients

There have been no previously published clinical randomized studies comparing Primoris®, short stem, hip prosthesis with standard uncemented hip arthroplasty in relation to bone density and function development. This is the subject for this study.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northern Orthopaedic Division, Clinic Farsø, Aalborg University Hospital

Farsø, Northern Jutland, Denmark

About this study

The overall purpose of this study is to show whether the Primoris® hip prosthesis results in a smaller loss of bone density than standard hip prosthesis, which in the longer term may result in an improved survival of prosthesis No. 2 after revision / replacement of a Primoris® hip prosthesis.

The primary outcome is periprosthetic bone quality in Primoris® hip prosthesis compared to standard hip prosthesis measured by DXA scanning.

The secondary outcomes are to assess:

  • The hip function measured by gait analysis.
  • Hip strength at pressure gauge.
  • Prosthetic migration / migration measured by radio-stereometric analysis (RSA).
  • Patient satisfaction measured by PROMs.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Women ≤ 45 years or men ≤ 55 years with hip osteoarthritis, suitable for hip prosthesis.

Patients who wish to participate in the project and give written consent after oral and written information.

Exclusion criteria

  • Patients with previous bone disease, metabolic disease, including diabetes, or the use of drugs that affect bone density.
  • Smoking more than 20 cigarettes daily
  • Patients with fracture in the femur or acetabulum.
  • Patients who do not understand the given patient information
  • Competing disorder requiring treatment with antiinflammatory drugs (NSAIDs, steroid, cytostatics).
  • Estimated residual life <10 years
  • Rheumatoid arthritis or other arthritis (eg psoriasis arthritis).
  • Previous surgery on the relevant hip joint.
  • Co-Morbidity (ASA Group 3-5).
  • Neurological disorder that compromises motor skills and rehabilitation.
  • Pregnancy.
  • Osteoarthritis secondary to mb. Calvé-Legg-Perthes / Avascular Caput Necrosis, Epiphysiolysis Capitis Femoris and Multiple Epiphysic Dysplasia.
  • Acetabular dysplasia with secondary subluxation (Crowe grade II to IV).
  • Previously detected osteoporosis or osteoporosis detected by current DXA scanning.
  • Ongoing treatment with osteoporosis medicine (bisphosphonates, estrogen receptor modulators and parathyroid hormone, etc.).
  • Aseptic caput necrosis (posttraumatic, idiopathic).
  • Varus or valgus deformity in proximal femur (collum angle <125 ° or> 145 °.)
  • Collum femoris assessed too retro- or anteverted.

Treatment and study plan

Total Hip Arthroplasty

Procedure

The usual procedures of the department: Moore incision and insertion of uncemented joints (exceed with vitamin E enriched polyethylene liner and 32 or 36 mm head). Cyclokaprone is administered peroperatively (bleeding-reducing), antibiotics and thrombosis prophylaxis. Follow the usual rehabilitation regimes, fast track, incl. Use of crutches and must support within the pain limit, possibly with crutches the first 4 weeks after surgery, then full load.

By default, postoperative X-ray and RSA recordings will be performed on the 1st or 2nd postoperative day. The surgery will be performed by specialist physicians in orthopedic surgery associated with the hip arthroplasty sector.

Primary outcomes

  1. Bone Mineral Density

    Time frame: 2 -10 years

    Bone density around the prosthesis measured by serial Dual X-ray Absorptiometry (DXA) scans.

Secondary outcomes

  1. Gait analysis

    Time frame: 1 year

    Walking function measured by gait analysis and hip strength at dynamometer test pre and 12 months postoperatively.

  2. Radio Stereometric Analysis (RSA)

    Time frame: 2-10 years

    Prosthetic migration / migration measured by X-ray Radio-stereophotogrametic-analyzes

  3. European Quality of life in 5 Dimensions (EQ5D)

    Time frame: 2-10 years

    This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.

  4. Harris Hip Score (HHS)

    Time frame: 2-10 years

    This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.

  5. Oxford Hip Score (OHS),

    Time frame: 2-10 years

    This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.

  6. University of California Los Angeles Activity Score (UCLA)

    Time frame: 2-10 years

    This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.

  7. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 2-10 years

    This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.

  8. Forgotten Joint Score (FJS)

    Time frame: 2-10 years

    This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.

Sponsors and collaborators

Lead sponsor

Northern Orthopaedic Division, Denmark

Other

Registry information

Official study title

Selection of Hip Prosthesis for Younger Patients? Primoris® Short Femur Component vs. Echo® Standard Femur Component. Comparison of Bone Re-modeling, Prosthetic Migration and Gait Function. Controlled Randomized Study of 60 Patients.

Important dates

Study start
2018
Primary completion
2019
Study completion
2029
First posted
Sep 12, 2017
Registry last updated
Apr 8, 2022

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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