- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Islam Mohamed Abd el hameed, Assistant lecturer
- Telefonnummer: 0201016329653
- E-post: islammohamed846@yahoo.com
Studera Kontakt Backup
- Namn: Mohamed Mostafa Alaa eldin and el aziz, Assistant professor
- Telefonnummer: 0201096967747
- E-post: Mohamed.m.alaa@aun.edu.eg
Studieorter
-
-
Asyut Governorate
-
Asyut, Asyut Governorate, Egypten
- Assiut University hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Harris hip score
Tidsram: Immediately post operative 3 months 6 months One year Two years
|
Immediately post operative 3 months 6 months One year Two years
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Oxford hip score
Tidsram: 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
Tidsram: 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
Tidsram: Duration of the operation
|
Duration of the operation
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- ORTHO-2026-015
Plan för individuella deltagardata (IPD)
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