Joint Disease
Conditions
Keywords
total hip arthroplasty, minimal invasive
Brief summary
Osteo introducer system is the instruments used in minimal invasive THA. This study will compare the minimal invasive THA using the osteo introducer system and THA using common instruments, to show the non-inferiority of osteo introducer system in safety and efficacy of THA surgery.
Interventions
PROCEDUREMinimum invasive total hip arthroplasty
Minimum invasive total hip arthroplasty using the osteo introducer system
PROCEDURECommon total hip arthroplasty
Common total hip arthroplasty using common instruments
Sponsors
Suzhou MicroPort OrthoRecon Co. LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* With indications of total hip arthroplasty (e.g. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis; rheumatoid arthritis; correction of functional deformity, etc.) * BMI\<30 * Subject is a candidate for primary total hip arthroplasty * No obvious congenital abnormality in hip joint * Subject has no mental illness, is willing to join the study voluntarily and sign the approved informed consent document; is willing and able to complete required study visits or assessments
Exclusion criteria
* Subjects with inadequate neuromuscular status (e.g., prior paralysis, fusion and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable * Overt infection * Distant foci of infections * Allergy to metals * Rapid disease progression as manifested by joint destruction or bone absorption apparent on X-ray * Skeletally immature * Neuropathic joints * Hepatitis or HIV infection * Neurological or musculoskeletal disease that may adversely affect gait or weight-bearing * Pregnant or lactating women * Subjects enrolled in another drug or device clinical investigation within 3 month * Investigator has judged the subject is not suitable for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation the restoration of hip function at 3 month | 3 month | Assessment the changes of Harris Hip Score at postoperative 3 month from preoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation the restoration of hip function at each time frame | 6 week, 3 month, 6 month | Assessment the Harris Hip Score at each time frame |
| Barthel Index | 1day, 3day, 2 week, 6 week, 3 month, 6 month | Assessment the daily living activity |
| Berg Balance Scale | 1day, 3day, 2 week, 6 week, 3 month, 6 month | Assessment the balance ability |
| Visual Analogue Scale | 1day, 3day, 2 week | Assessment the degree of pain |
| Evaluation of X-ray | 1day, 6 week, 6 month | Assessment of position, confirm whether there is loosening, dislocation or fracture etc. |
| Adverse events | up to 6 month | Investigate all the adverse events happened during the study period |
| Laboratory Examinations | 3 day, 6 week | Collect the following laboratory results which reflect the traumatic stress:Glu, CRP, Alb, CK, TBA, UA, Ca, Mg, WBC, GRA |
| Dislocation rate | 1day, 3day, 2 week, 6 week, 3 month, 6 month | Compare the dislocation rate |
| The use of analgesics | 1day, 3day, 2 week, 6 week, 3 month, 6 month | Investigate the name and dosage of analgesics to indirectly assess the degree of pain |
Countries
China
Outcome results
None listed