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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hip Arthropathy
• Intervention / Treatment: Other: The posterolateral approach; Other: Direct anterior technique

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
hip's range of motion.	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Anticipated): March 23, 2018
• Primary Completion (Anticipated): December 20, 2019
• Study Completion (Anticipated): January 20, 2020

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 21, 2018

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: perception; hip arthroplasty; physical fitness; surgeries; autonomy; energetic cost
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: PI2017_843_0023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No