- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04935281
Percutaneous Repair of Acute Achilles Tendon Rupture With Assistance of Intraoperative Ultrasound
19. juni 2021 opdateret af: ahmed m. samy, Tanta University
Percutaneous Repair of Acute Achilles Tendon Rupture With Assistance of Intraoperative Ultrasound: Does it Improves the Results of Repair?
This is a prospective randomized controlled study carried out between May 2016 and December 2020.
It included 98 patients presented with acute rupture of Achilles tendon The patients were randomly distributed by closed envelop technique (49 in each group).
Group A included those managed with the assistant of an intra-operative ultrasound.
Group B included those done without ultrasound assistant
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
A preoperative prophylactic dose of antibiotic was given intravenously in the form of 2gm of cephalosporin one hour before operation.
Under general or regional anesthesia, the patient laid in prone position without a tourniquet and both feet out of the table for easily mobilization of the ankle joint.
In group A, an intraoperative ultrasound was done by a radiologist before the repair for identification the course of sural nerve and outline the medial and lateral edges of torn tendon.
Then ultrasound was repeated after repair for confirmation of adequate contact of both stumps and satisfactory strength of the repair by visualization of the tendon with passive motion of the ankle.
For patients in group B, the course of the sural nerve was determined according to the technique described by Blackmon et al.
This technique depends on the leg length for location the point where the nerve crosses the lateral edge of the tendon.
The medial and lateral borders of both stumps were outlined by palpation with identification of the gap in-between.
The technique of repair was standardized for all patients in both groups.
We used the technique described by Maffulli et al
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
91
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 50 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
a prospective randomized control study
Beskrivelse
Inclusion Criteria:
- age between 18 and 50 years
- acute ( not more than two weeks) closed complete injury
- injury of Achilles tendon in zone 2 (the area between 3 and 6 cm from the insertion) according to Langergran and Lindholm
Exclusion Criteria:
- incomplete injury
- recurrent injury
- associated fracture ankle or foot
- previous history of local corticosteroids injection
- patients with neurovascular problem (e.g. diabetic, autoimmune …etc), smoking, and alcoholics
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
percutaneous repair with an intraoperative assissted ultrasound
a radiologist did an intraoperative ultrasound before the repair for identification the course of sural nerve and outline the medial and lateral edges of torn tendon.
|
Under general or regional anesthesia, the patient laid in prone position In group A, an intraoperative ultrasound was done by a radiologist before the repair .
|
|
percutaneous repair without an intraoperative assissted ultrasound
the course of the sural nerve was determined according to the technique described by Blackmon et al .This technique depends on the leg length for location the point where the nerve crosses the lateral edge of the tendon
|
For patients in group B, the course of the sural nerve was determined according to the technique described by Blackmon et al.The medial and lateral borders of both stumps were outlined by palpation with identification of the gap in-between.
We used the technique described byMaffulli et al with six stab incisions, one cm each.
Four incisions were on medial and lateral edge of the proximal stump and the other two were around distal stump.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
American Orthopedic Foot and An¬kle Society score
Tidsramme: 4 years
|
score from 0 to 100 with highest score is better
|
4 years
|
|
single leg rising
Tidsramme: 3 years
|
ability to stand on one leg
|
3 years
|
|
magnetic resonance image
Tidsramme: one year
|
assessment of healing of torn tendon
|
one year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. maj 2016
Primær færdiggørelse (Faktiske)
1. marts 2020
Studieafslutning (Faktiske)
1. december 2020
Datoer for studieregistrering
Først indsendt
27. maj 2021
Først indsendt, der opfyldte QC-kriterier
19. juni 2021
Først opslået (Faktiske)
22. juni 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juni 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. juni 2021
Sidst verificeret
1. juni 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Tanta H
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Acute Rupture of Achilles Tendon
-
The University of Texas Health Science Center,...Trukket tilbagePreterm Prelabor Rupture of Membranes (PPROM)Forenede Stater