Northern Orthopaedic Division, Clinic Farsø, Aalborg University Hospital
Farsø, Northern Jutland, Denmark
NCT Number: NCT03279276
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.
This study is active but is not currently recruiting participants.
18 year–55 year
All sexes
Interventional
Not applicable
Farsø, Northern Jutland, Denmark
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:
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
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.
Time frame: 2 -10 years
Bone density around the prosthesis measured by serial Dual X-ray Absorptiometry (DXA) scans.
Time frame: 1 year
Walking function measured by gait analysis and hip strength at dynamometer test pre and 12 months postoperatively.
Time frame: 2-10 years
Prosthetic migration / migration measured by X-ray Radio-stereophotogrametic-analyzes
Time frame: 2-10 years
This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
Time frame: 2-10 years
This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
Time frame: 2-10 years
This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
Time frame: 2-10 years
This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
Time frame: 2-10 years
This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
Time frame: 2-10 years
This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
Northern Orthopaedic Division, Denmark
Other
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.
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.
Published trials that share one or more normalized conditions with this study.
NCT04754087
Arthritis, Avascular Necrosis of Hip
Denver, Colorado, United States
View Trial DetailsNCT07386561
Anxiety Disorders, Arthritis
Trzebnica, Lower Silesian Voivodeship, Poland
View Trial DetailsNCT03113981
Arthritis, Bone Diseases
Bordeaux, France
View Trial DetailsNCT03608579
Arthritis, Joint Diseases
Rochester, Minnesota, United States
View Trial Details