Minimally Invasive Surgery of the Hip Versus Standard Approach

Osteoarthritis Clinical Trial

Official title:

Minimally Invasive Surgery of the Hip: A Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261040
• Other study ID #: OHREB 2003211-01H
• Status: Completed
• Phase: N/A
• Start date: June 2003
• Est. completion date: May 2011

Study information

• Verified date: March 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthroplasty
• Osteoarthritis

Intervention

Procedure:
• Minimally Invasive Surgery
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Zimmer Biomet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Outcomes	Hospital length of stay	24 months
Secondary	Harris Hip Score	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."	24 months
Secondary	Change in Timed Get-up-and-Go Test (TUG)	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 months
Secondary	Operating Time Duration	Duration of the surgical procedure	Day of Surgery
Secondary	Estimated Blood Loss	Estimated blood loss during the operative procedure	Day of surgery