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Completed

NCT Number: NCT03113591

Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty

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.

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Key information

Conditions

Joint Disease Joint Diseases Musculoskeletal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimum invasive total hip arthroplasty

Procedure

Minimum invasive total hip arthroplasty using the osteo introducer system

Common total hip arthroplasty

Procedure

Common total hip arthroplasty using common instruments

Primary outcomes

  1. Evaluation the restoration of hip function at 3 month

    Time frame: 3 month

    Assessment the changes of Harris Hip Score at postoperative 3 month from preoperative

Secondary outcomes

  1. Evaluation of X-ray

    Time frame: 1day, 6 week, 6 month

    Assessment of position, confirm whether there is loosening, dislocation or fracture etc.

  2. Evaluation the restoration of hip function at each time frame

    Time frame: 6 week, 3 month, 6 month

    Assessment the Harris Hip Score at each time frame

  3. Barthel Index

    Time frame: 1day, 3day, 2 week, 6 week, 3 month, 6 month

    Assessment the daily living activity

  4. Berg Balance Scale

    Time frame: 1day, 3day, 2 week, 6 week, 3 month, 6 month

    Assessment the balance ability

  5. Visual Analogue Scale

    Time frame: 1day, 3day, 2 week

    Assessment the degree of pain

  6. The use of analgesics

    Time frame: 1day, 3day, 2 week, 6 week, 3 month, 6 month

    Investigate the name and dosage of analgesics to indirectly assess the degree of pain

  7. Adverse events

    Time frame: up to 6 month

    Investigate all the adverse events happened during the study period

  8. Laboratory Examinations

    Time frame: 3 day, 6 week

    Collect the following laboratory results which reflect the traumatic stress:Glu, CRP, Alb, CK, TBA, UA, Ca, Mg, WBC, GRA

  9. Dislocation rate

    Time frame: 1day, 3day, 2 week, 6 week, 3 month, 6 month

    Compare the dislocation rate

Sponsors and collaborators

Lead sponsor

Suzhou MicroPort OrthoRecon Co. LTD

Other

Registry information

Official study title

Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty: A Prospective, Multicenter, Randomized Controlled Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Apr 13, 2017
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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