- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Islam Mohamed Abd el hameed, Assistant lecturer
- Telefonnummer: 0201016329653
- E-mail: islammohamed846@yahoo.com
Undersøgelse Kontakt Backup
- Navn: Mohamed Mostafa Alaa eldin and el aziz, Assistant professor
- Telefonnummer: 0201096967747
- E-mail: Mohamed.m.alaa@aun.edu.eg
Studiesteder
-
-
Asyut Governorate
-
Asyut, Asyut Governorate, Egypten
- Assiut University hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Harris hip score
Tidsramme: Immediately post operative 3 months 6 months One year Two years
|
Immediately post operative 3 months 6 months One year Two years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Oxford hip score
Tidsramme: 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
Tidsramme: 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
Tidsramme: Duration of the operation
|
Duration of the operation
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- ORTHO-2026-015
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Surgical approaches: direct lateral approach for the hip and SuperPATH approach
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Ottawa Hospital Research InstituteMicroPort Orthopedics Inc.RekrutteringArtroplastik, udskiftning, hofteCanada