Evaluation of efficacy of plasma-treated femoral stems in total hip arthroplasty

Evaluation on Clinical Effects and Outcomes of Increased Hydrophilicity by Plasma Treatment to Microporous Titanium-coated Femoral Stems in Total Hip Arthroplasty

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006906

Enrollment

120

Registered

2022-01-07

Start date

2022-04-25

Completion date

Unknown

Last updated

2022-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : This multi-center (5 institutes, 6 surgeons) study is designed to prospectively enroll 120 patients (20 patients per surgeon (10 controlled, 10 experimental) who agreed to informed co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who agreed with informed consent. 2. Both genders over 65 years of ahe 3. Hip disorders with indications of total hip arthroplasty

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Harris hip score (HHS)	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactJi Hoon Bahk

The Catholic University of Korea, Seoul St. Mary's Hospital

tonybahk@gmail.com+82-2-2258-6615

Outcome results