Randomised clinical trial assessing migration of uncemented primary total hip replacement stems, with and without autologous impaction bone grafting.

Not Applicable

Active, not recruiting

• Conditions: on-inflammatory arthritis of the hip; Non-inflammatory arthritis of the hip; Inflammatory arthritis of the hip; Surgery - Surgical techniques; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12618000652279
• Lead Sponsor: Riaz Khan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-24
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion Criteria
1. The individual clinically qualifies for total hip arthroplasty surgery based on physical examination and medical history.
2. The individual is diagnosed with an inflammatory or non inflammatory degenerative joint disease.
3. The individual has not had a previous total hip replacement or hip fusion of the affected hip joint.
4. The individual is physically and mentally willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation (i.e. not diagnosed with active significant psychiatric disorder, senile dementia, Alzheimer’s disease, presence of alcohol or substance abuse).
5. The individual is skeletally mature.
6. The individual has no plans to relocate to another geographic area before the completion of the study thus precluding scheduled follow-up.

Exclusion Criteria

Exclusion Criteria
1. The individual is unable or unwilling to sign the Patient Informed Consent specific to this study.
2. The individual is less than 60 years of age.
3. The individual is classified as morbidly obese (body mass index 40 or greater).
4. The individual has an active infection within the considered hip joint.
5. Any condition where quality of bone graft from the femoral head is poor and therefore not able to be used (e.g. avascular necrosis).
6. The individual has a neuromuscular or neurosensory deficiency that limits the ability to evaluate the safety and effectiveness of the surgery.
7. The individual has a diagnosed systemic disease that would affect the subject’s welfare or overall outcome of the study (i.e. Paget's disease, renal osteodystrophy), is not immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
8. The individual is pregnant.
9. The individual is a prisoner.

Study & Design

• Study Type: Interventional
• Study Design: Not specified