Total Hip Arthroplasty Clinical Trial
Official title:
Direct Anterior Versus Posterior Approach for Total Hip Arthroplasty: a Multicentric Prospective Randomized Clinical Study
Verified date | September 2018 |
Source | Hopital du Sacre-Coeur de Montreal |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Determining the best approach for a total hip arthroplasty (THA) implies that the procedure is kind on soft tissues, with the lowest complication rates, and easily reproducible. Although there have been several attempts to resolve this issue in the last decade, a definitive answer has not been found. Therefore, the investigators performed a prospective study to compare direct anterior versus posterior approach based on (1) hospital stay, (2) functional outcome, (3) pain, (4) implant position (5) complications and (6) surgical time.
Status | Completed |
Enrollment | 50 |
Est. completion date | August 1, 2013 |
Est. primary completion date | July 1, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - primary total hip replacement due to osteoarthrosis or osteonecrosis - patients older than 50 years. Exclusion Criteria: - inflammatory arthritis, - any previous ipsilateral hip surgery - suffering from proximal femoral deformity - BMI over 40 - active infection - severe contralateral hip disease, muscle contractures or neuromuscular pathology - requiring structural bone grafts. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hopital du Sacre-Coeur de Montreal |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hospital stay | Length in days of hospital stay | Between 0 days and 1 month, average of 4 days | |
Secondary | functional recovery | The Harris Hip Score (HHS) was used to measure pain and function.Grading for the Harris Hip Score is interpreted on a scale of 0 to 100 as follows: results <70 are Poor; 70 - 79 are Fair; 80-89 are Good; 90 -100 are Excellent | 2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively | |
Secondary | pain assessment: VAS | Visual Analog Scale (VAS) was used. The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases. The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The pain VAS is a single-item scale, anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) . It is one total score, without subscale. As the lowest score of zero means no pain, it is the best possible outcome. As the highest score of 100 means the worst imaginable pain, it is the worst possible outcome. | 2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively | |
Secondary | implant position | Radiological assessment | 2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively | |
Secondary | number of patients with per/post surgical complications. | Possible complications are: peroperative fracture, hip dislocation, infection, neurologic complication, vascular complication or hematoma. | 2 weeks, 4 weeks, 3 months, 6 months, 1 year, 2 years and 5 years postoperatively | |
Secondary | surgical time | Surgical time in minutes | Up to 240 minutes |
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