Clinical trial NCT03113591: Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty
Official title: Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty: A Prospective, Multicenter, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Disease
Keywords: total hip arthroplasty
minimal invasive
Lead sponsor: Suzhou MicroPort OrthoRecon Co. LTD
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation the restoration of hip function at 3 month
timeFrame: 3 month
Secondary outcomes:
measure: Evaluation of X-ray
timeFrame: 1day, 6 week, 6 month
measure: Evaluation the restoration of hip function at each time frame
timeFrame: 6 week, 3 month, 6 month
measure: Barthel Index
timeFrame: 1day, 3day, 2 week, 6 week, 3 month, 6 month
measure: Berg Balance Scale
timeFrame: 1day, 3day, 2 week, 6 week, 3 month, 6 month
measure: Visual Analogue Scale
timeFrame: 1day, 3day, 2 week
measure: The use of analgesics
timeFrame: 1day, 3day, 2 week, 6 week, 3 month, 6 month
measure: Adverse events
timeFrame: up to 6 month
measure: Laboratory Examinations
timeFrame: 3 day, 6 week
measure: Dislocation rate
timeFrame: 1day, 3day, 2 week, 6 week, 3 month, 6 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
Study officials:
References: