An interventional study of Total Hip Arthroplasty in Osteoarthritis, Hip, sponsored by Northern Orthopaedic Division, Denmark. Active, not recruiting at 1 site in Denmark. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-04-08.
Sponsored by Northern Orthopaedic Division, Denmark · Not applicable, Interventional, and Treatment
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.
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:
641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.
This study's enrollment of 60 is below the median of 90 across 457 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Northern Orthopaedic Division, Denmark is the lead sponsor of 61 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Total hip arthroplasty surgery using a Primoris® femur component, Exceed ® acetabular cup + E-poly liner ®.
Procedure: Total Hip Arthroplasty
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.
Bone Mineral Density
Bone density around the prosthesis measured by serial Dual X-ray Absorptiometry (DXA) scans.
Time frame: 2 -10 years
Gait analysis
Walking function measured by gait analysis and hip strength at dynamometer test pre and 12 months postoperatively.
Time frame: 1 year
Radio Stereometric Analysis (RSA)
Prosthetic migration / migration measured by X-ray Radio-stereophotogrametic-analyzes
Time frame: 2-10 years
European Quality of life in 5 Dimensions (EQ5D)
This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
Time frame: 2-10 years
Harris Hip Score (HHS)
This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
Time frame: 2-10 years
Oxford Hip Score (OHS),
This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
Time frame: 2-10 years
University of California Los Angeles Activity Score (UCLA)
This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
Time frame: 2-10 years
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
Time frame: 2-10 years
Forgotten Joint Score (FJS)
This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
Time frame: 2-10 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2018 to primary completion in Dec 2019, 18 months.
Of 200 non-industry interventional studies with no phase under Osteoarthritis, Hip, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's 18 months is below that.
Counting every sponsor, half of 226 studies reached it within 29 months; a quarter within 14 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Northern Orthopaedic Division, Denmark