Evaluation of efficacy of plasma-treated femoral stems in total hip arthroplasty
- Conditions
- Diseases of the musculoskeletal system and connective tissue
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
1. Patients who agreed with informed consent.
2. Both genders over 65 years of ahe
3. Hip disorders with indications of total hip arthroplasty
1. Has hip fractures requiring total hip arthroplasty
2. Has Active infections including sepsis and osteomyelitis in joint lesions.
3. Has low bone stock or osteoporosis which requires cemented fixation of acetabular cups
4. Has Metabolic disorders which can alter bone formation metabolism
5. Has osteomalacia
6. Possesses infection foci which can potentially spread to the hip joint
7. Confirmed rapid joint destruction, prominent bone loss or osteolysis on preoperative X-rays.
8. Has Vascular insufficiency or neuromuscular disorders including muscular dystrophy, which can undermine outcomes of arthroplasty
9. Has any concomitant disease which is likely to jeopardize the functioning or success of the implant
10. Has a known sensitivity or allergy to one or more of the implanted materials, including but not limited to chromium, cobalt, and/or ceramic
11. Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails
12. Has participated to other clinical trials within 6 months period at time of the screening
13. Has been determined to be ineligible to participate in the trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Harris hip score (HHS)
- Secondary Outcome Measures
Name Time Method Pain score (NRS) around the hip joint;Pain medications prescribed to reported pain ;The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) ;EuroQol-5 dimension (EQ-5D index score);Time (in days) to postoperative ambulation ;Hip radiographs;Pelvic bone 3D CT