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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03472755
Other study ID # PI2017_843_0023
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 23, 2018
Est. completion date January 20, 2020

Study information

Verified date December 2020
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Recent increased interest in tissue-sparing and minimally invasive arthroplasty has given rise to a sharp increase in the utilization of direct anterior total hip arthroplasty.


Description:

- Purpose: The direct anterior approach to the hip has been suggested to have several advantages compared to previously classical approaches. However, no studies focused on the effects of these different surgeries on patients' perception recovery and walking efficiency according the initial physical fitness. Therefore, the purpose of this study is to compare the effects of surgical procedures on perceptual walking skills and efficiency according to the patients' physical fitness. - Abstract : Some earlier studies report differences between surgery types in self- reported mobility, functional recovery and residual hip pain. The direct anterior approach to the hip has been suggested to have several advantages compared to previously popular approaches through its use of an intra-muscular and intra-nervous interval between the tensor fasciae latae and sartorius muscles. However, patients' physical fitness, postural response and perceptual walking skill relation was not taking account. 80 patients will be tested, one before and at various times after hip surgery. In randomized conditions, our patients will be divided in two groups, according the surgery approaches and their physical fitness. All patients performed a Performance-Oriented Mobility Assessment Walking test with and without step and the PMA, Harris, Oxford 12 and Womac scores will be evaluated before, 3 weeks, 6 weeks, 3 months and 1 year after the surgery. During the Performance-Oriented Mobility Assessment Walking test, self-reported walking capacity, rating of exertion perception and walking parameters will be measured.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 20, 2020
Est. primary completion date December 20, 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility Inclusion Criteria: - Age > 50 years - Body mass index < 35 - Scheduled hip arthroplasty surgery - Exclusion Criteria: - No health coverage - Age > 85 years - Body mass index = 35 - Cognitive impairment (score Mini Mental Statue < 24) - Any other osteo-articular diseases than the operated hip, any muscular or neurological diseases that could penalize the walk

Study Design


Related Conditions & MeSH terms


Intervention

Other:
The posterolateral approach
The posterolateral approach was used for implantation among patients in lateral position. This approach goes through the gluteus maximus, the piriformis and superior gemeli muscles are detached and later reattached to bone
Direct anterior technique
patients were fixed in a supine position, a small entry incision was made in the vessel free interval between the tensor fasciae latae and the sartorius muscles and the prosthesis socket were put in place. Via a second dorsal incision, after releasing the external rotators, the prosthesis stem and ball were implanted and the two parts of the prosthesis were attached

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Outcome

Type Measure Description Time frame Safety issue
Primary hip's range of motion. 1 year
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