Selecting the Right Hip Prosthesis for Young Patients

Osteoarthritis, Hip Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03279276
• Other study ID #: N-20170030
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 2029

Study information

• Verified date: April 2022
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2029
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

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.

Locations

Country	Name	City	State
Denmark	Northern Orthopaedic Division, Clinic Farsø, Aalborg University Hospital	Farsø	Northern Jutland

Sponsors (1)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density	Bone density around the prosthesis measured by serial Dual X-ray Absorptiometry (DXA) scans.	2 -10 years
Secondary	Gait analysis	Walking function measured by gait analysis and hip strength at dynamometer test pre and 12 months postoperatively.	1 year
Secondary	Radio Stereometric Analysis (RSA)	Prosthetic migration / migration measured by X-ray Radio-stereophotogrametic-analyzes	2-10 years
Secondary	European Quality of life in 5 Dimensions (EQ5D)	This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.	2-10 years
Secondary	Harris Hip Score (HHS)	This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.	2-10 years
Secondary	Oxford Hip Score (OHS),	This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.	2-10 years
Secondary	University of California Los Angeles Activity Score (UCLA)	This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.	2-10 years
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.	2-10 years
Secondary	Forgotten Joint Score (FJS)	This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.	2-10 years