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Completed

NCT Number: NCT00261040

Minimally Invasive Surgery of the Hip Versus Standard Approach

The purpose of this study is to determine if there is a difference in terms of length of hospital stay and post-operative outcomes between patients whose total hip replacement surgery is performed with a minimally invasive versus standard surgical approach.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Traditional techniques for total hip arthroplasty (THA) require complete visualization of the acetabulum and proximal femur since anatomic landmarks are crucial for correct orientation of the prosthetic components. All surgeons are taught that a wide surgical exposure is one of the most important factors in performing successful THA. Traditionally, it was impossible to achieve accurate fixation and orientation of the components without complete visualization of bony landmarks. These extensile exposures facilitate accurate implant alignment, but at the expense of more extensive soft tissue dissection. Little clinical research has been undertaken to relate the surgical approach to postoperative complications or patient function. Furthermore, despite the good overall results of THA, the recovery time to improved function can be lengthy. Blood loss is expected to be directly related to the extent of the surgical exposure and to influence patients outcomes. Based upon these facts, an important principle of arthroplasty surgery is to minimize the amount of soft tissue trauma while being able to achieve the surgical goal of reconstructing the arthritic hip joint. By definition, minimally invasive surgical (MIS) procedures result in less soft tissue disruption, which in turn should reduce pain, expedite healing, decrease recovery time, and potentially reduce the number of associated complications.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

BMI > 30 kg/m2 No prior ipsilateral hip surgery Osteoarthritis

Exclusion criteria

Patients with grossly distorted bony anatomy whereby standard implants are contraindicated; i.e. congenital dysplasia of the hip, proximal femoral abnormalities, etc

Rheumatoid Arthritis

Treatment and study plan

Minimally Invasive Surgery

Procedure

In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her.

Standard surgery

Procedure

The standard way that an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision.

Other names: non applicable

Primary outcomes

  1. Clinical Outcomes

    Time frame: 24 months

    Hospital length of stay

Secondary outcomes

  1. Harris Hip Score

    Time frame: 24 months

    Questionnaire to measure health outcome status. An index score of 100 is the highest score and is indicative of better outcome, while 0 is the lowest score and indicative of worse outcome. With regards to health, a score between 90-100 is considered "Excellent." 80-89 is considered "Good." 70-79 is considered "Fair." Less than 70 is considered "Poor."

  2. Change in Timed Get-up-and-Go Test (TUG)

    Time frame: 3 months

    A timed assessment to assess a participants mobility. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. A faster time is indicative of better mobility, while a slower time is indicative of worse mobility.

  3. Operating Time Duration

    Time frame: Day of Surgery

    Duration of the surgical procedure

  4. Estimated Blood Loss

    Time frame: Day of surgery

    Estimated blood loss during the operative procedure

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Zimmer Biomet

Registry information

Official study title

Minimally Invasive Surgery of the Hip: A Randomized Study

Important dates

Study start
2003
Primary completion
2010
Study completion
2011
First posted
Dec 2, 2005
Registry last updated
Mar 27, 2020

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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