Selecting the Right Hip Prosthesis for Young Patients

N/AActive Not RecruitingNCT03279276

Northern Orthopaedic Division, Denmark60 enrolled

Overview

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: 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Osteoarthritis, Hip

Interventions

Total Hip ArthroplastyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (1)

Northern Orthopaedic Division, Clinic Farsø, Aalborg University Hospital

Farsø, Northern Jutland, Denmark

Outcomes

Primary Outcomes

Bone Mineral Density

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

Time frame: 2 -10 years

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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