- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07633925
Short-term Results of SuperPATH Versus Direct Lateral Approach In Primary Total Hip Arthroplasty: A Randomized Controlled Study.
Total hip arthroplasty (THA) has shown great success in relieving joint pain and disability and has been a procedure of choice for the treatment of end-stage degenerative joint diseases and trauma.
There are multiple surgical approaches for THA, including the traditional posterior approach, anterior approach, lateral approach, anterolateral approach and posterolateral approach; each has its advantages and complications.
Modified direct lateral approach is considered as standard, most commonly used and familiar in Assiut university Arthroplasty centre. Yet it may cause abductor weakness, post operative pain, prolonged rehabilitation time and more blood loss.
In the past two decades, the group of micro-posterior approaches was introduced. In 2004 Stephen Murphy developed the Supecapsular (SuperCap) approach, preparing the hip insitu to reduce soft tissue traumatization caused by the dislocation manoeuvre used in the conventional posterior approach. , In 2008 Brad Penenberg developed the percutaneously-assisted total hip (PATH) app, a tissue-sparing approach leading through the interval between gluteus medius and the conjoined tendon of the external rotators.
In2011, James Chow described the supercapsular percutaneously-assisted total hip (SuperPATH) approach, the most Important features of SuperPATH are the following: (a) muscle sparing between gluteus medius and piriformis without detaching external rotator tendons or disrupting the hip capsule, (b) femur preparation first without dislocation (c) percutaneous acetabular preparation.
SuperPATH approach is designed to reduce soft tissue trauma and so blood loss, post operative pain, improve joint stability and allow earlier mobilization of patients.
Despite the theoretical advantages of the SuperPATH approach, its adoption remains limited compared with conventional surgical approaches. Furthermore, there is ongoing debate regarding its clinical superiority in terms of functional outcomes, complication rates and implant position.
Aim of our study is to evaluate the clinical and functional outcomes of total hip arthroplasty performed using SuperPATH compared to modified direct lateral approach.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Islam Mohamed Abd el hameed, Assistant lecturer
- Phone Number: 0201016329653
- Email: islammohamed846@yahoo.com
Study Contact Backup
- Name: Mohamed Mostafa Alaa eldin and el aziz, Assistant professor
- Phone Number: 0201096967747
- Email: Mohamed.m.alaa@aun.edu.eg
Study Locations
-
-
Asyut Governorate
-
Asyut, Asyut Governorate, Egypt
- Assiut University hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primary total hip arthroplasty.
- Age > 18 years.
- Body mass index < 40 kg/m2.
- Able to ambulate preoperative.
Exclusion Criteria:
- Hip deformity (acetabular or femoral).
- Ankylosed hips.
- Severe osteoporosis.
- Neuromuscular disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Direct lateral approach
total hip arthroplasty via direct lateral approach
|
Direct lateral approach is approach through the intra muscular septum of gluteus medial muscle SuperPATH approach is minimally invasive posterolateral approach for the hip
|
|
Experimental: SuperPATH
This arm will include patients who will undergo total hip arthroplasty via SuperPATH approach
|
Direct lateral approach is approach through the intra muscular septum of gluteus medial muscle SuperPATH approach is minimally invasive posterolateral approach for the hip
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Harris hip score
Time Frame: Immediately post operative 3 months 6 months One year Two years
|
Immediately post operative 3 months 6 months One year Two years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Oxford hip score
Time Frame: Immediately post operative 3 months 6 months One year Two years
|
Immediately post operative 3 months 6 months One year Two years
|
|
Visual analogue score
Time Frame: Immediately post operative 3 months 6 months One year Two years
|
Immediately post operative 3 months 6 months One year Two years
|
|
Operative time in minutes
Time Frame: Duration of the operation
|
Duration of the operation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ORTHO-2026-015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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