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Selecting the Right Hip Prosthesis for Young Patients

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ClinicalTrials.gov Identifier: NCT03279276
Recruitment Status : Not yet recruiting
First Posted : September 12, 2017
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Procedure: Total Hip Arthroplasty Not Applicable

Detailed Description:

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:

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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.
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2029

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Primoris
Total hip arthroplasty surgery using a Primoris® femur component, Exceed ® acetabular cup + E-poly liner ®.
Procedure: Total Hip Arthroplasty

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.


Active Comparator: Echo
Total hip arthroplasty surgery using a standard uncemented Echo® femur component, Exceed ® acetabular cup + E-poly liner ®.
Procedure: Total Hip Arthroplasty

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 Outcome Measures :
  1. Bone Mineral Density [ Time Frame: 2 -10 years ]
    Bone density around the prosthesis measured by serial Dual X-ray Absorptiometry (DXA) scans.


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279276


Contacts
Contact: Mogens B Laursen, MD, PhD +45 20946846 mogens.berg.laursen@rn.dk
Contact: Anders Tjønneland, MD anders.tjonneland@gmail.com

Locations
Denmark
Northern Orthopaedic Division, Clinik Farsoe, Aalborg University Hospital
Aalborg, Northern Jutland, Denmark
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Investigators
Principal Investigator: Mogens B Laursen, MD, PhD Northern ODD

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT03279276     History of Changes
Other Study ID Numbers: N-20170030
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Northern Orthopaedic Division, Denmark:
Hip arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases