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Comparison of Direct Anterior and Posterior Surgical Approaches in Regards to the Patient' Physical Characteristics (MOPHEM)

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ClinicalTrials.gov Identifier: NCT03472755
Recruitment Status : Withdrawn (difficulty in setting up the study in the investigator site)
First Posted : March 21, 2018
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief 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.

Condition or disease Intervention/treatment Phase
Hip Arthropathy Other: The posterolateral approach Other: Direct anterior technique Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients provided written informed consent to participate in this study, as approved by the local ethics committee. Prior to surgery, patients were informed about the benefits and risk of the conventional posterolateral and direct anterior approaches. Then they performed postural test and a Performance-Oriented Mobility Assessment Walking test with and without step. After randomization, patients were operated according the conventional posterolateral or direct anterior techniques.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Subjective Walking Capacity : Comparison of Direct Anterior and Posterior Surgical Approaches in Regards to the Patient' Physical Characteristics (MOPHEM)
Estimated Study Start Date : March 23, 2018
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : January 20, 2020

Arm Intervention/treatment
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
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 techniques.
. In the 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.
Other: 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




Primary Outcome Measures :
  1. hip's range of motion. [ Time Frame: 1 year ]


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03472755    
Other Study ID Numbers: PI2017_843_0023
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
hip arthroplasty
surgeries
physical fitness
perception
energetic cost
autonomy
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases