Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome
5. mai 2015 oppdatert av: Region Skane
Endoscopic Versus Open Carpal Tunnel Release: 10 to 15 Years Follow-up of a Randomized Controlled Trial
No randomized trials have compared long-term outcomes following endoscopic and open carpal tunnel release in patients with carpal tunnel syndrome (CTS).
The investigators conducted a single-center randomized controlled trial between January 1998 and December 2002, including 128 patients (25 to 60 years) with clinically diagnosed and electrophysiologically confirmed idiopathic CTS.
The outcome measures included the validated CTS symptom severity and functional status scales completed at baseline and 1 year postoperatively.
The trial showed that the 1-year outcomes of open and endoscopic carpal tunnel release regarding symptoms and function were equivalent.
This extended follow-up of the randomized trial will primarily measure the symptom outcomes at 10-15 years after surgery.
A questionnaire will be sent by mail to the patients.
The questionnaire will consist of the CTS symptom severity and functional status scales, the 6-item CTS symptoms scale (CTS-6), the 11-item disabilities of the arm, shoulder and hand (QuickDASH), the 2-item palmar pain scale, and a visual analog scale about treatment satisfaction.
The patients will also be asked about whether they had undergone further surgery for CTS in the same or contralateral hand after their operation in the randomized trial.
The completed questionnaires will be scanned into a database.
The scores for the different scales will be calculated.
Analysis will include comparison between the open and endoscopic groups as well as within-group changes of scores from 1 year to 10-15 years.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
124
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
25 år til 60 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria (original trial):
- Primary idiopathic carpal tunnel syndrome
- age 25-60 years
- currently employed
- duration of symptoms of at least three months
- inadequate response to six weeks' treatment with wrist splint
- symptoms of classic or probable carpal tunnel syndrome according to the diagnostic criteria in the Katz hand diagram, and nerve conduction test showing median neuropathy at the wrist (distal motor latency ≥4.5 milliseconds, wrist-digit sensory latency ≥3.5 milliseconds, or sensory conduction velocity at the carpal tunnel segment <40 metres/second but no other abnormalities.
Exclusion Criteria (original trial):
Inflammatory joint disease
- diabetes mellitus, thyroid disorder, pregnancy, trauma to the affected hand during the preceding year
- previous carpal tunnel release surgery in the affected hand
- carpal tunnel release surgery in the contralateral hand during the preceding year
- symptoms of carpal tunnel syndrome in the contralateral hand not adequately relieved by splint at the time of enrollment
- current sick leave because of disorders other than carpal tunnel syndrome
- inability to complete questionnaires because of language problem or cognitive disorder.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Open surgery
Open surgery is Open carpal tunnel release
|
Open carpal tunnel release using conventional open technique under local anesthesia and tourniquet.
The incision in the open procedure extended from about 1 cm proximal to 3 cm distal to the wrist crease.
The transverse carpal ligament was divided; no additional procedures were performed.
a soft dressing was applied.
Dressing and sutures were removed 10 days postoperatively.
Andre navn:
|
|
Eksperimentell: Endoscopic surgery
Endoscopic surgery is 2-portal endoscopic carpal tunnel release
|
Surgery dwas done under local anesthesia injected at the portal sites only.
Tourniquet was used.
Each of the two skin incisions in the endoscopic procedure was 1 cm long.
With the endoscope inserted from the distal portal and a hook knife inserted from the proximal portal, the transverse carpal ligament was divided from its distal edge to its proximal edge.
Incisions were closed with non-absorbables sutures and a soft dressing was applied.
Sutures were removed 10 days postoperatively.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in CTS symptom severity score
Tidsramme: Baseline to 10-15 years postoperatively
|
Baseline to 10-15 years postoperatively
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Rate of repeat surgery
Tidsramme: 10-15 years postoperatively
|
10-15 years postoperatively
|
|
Change in CTS functional status score
Tidsramme: from baseline and 1 year to 10-15 years postoperatively
|
from baseline and 1 year to 10-15 years postoperatively
|
|
Residual pain in the scar or proximal palm
Tidsramme: 10-15 years postoperatively
|
10-15 years postoperatively
|
|
Patient satisfaction with the results of surgery
Tidsramme: 10-15 years postoperatively
|
10-15 years postoperatively
|
|
Change in CTS symptom severity score
Tidsramme: 1 year to 10-15 years postoperatively
|
1 year to 10-15 years postoperatively
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
CTS-6 score
Tidsramme: 10-15 years postoperatively
|
10-15 years postoperatively
|
|
QuickDASH score
Tidsramme: 10-15 years postoperatively
|
10-15 years postoperatively
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Isam Atroshi, MD, PhD, Clinical Sciences, Lund University, Sweden
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Atroshi I, Larsson GU, Ornstein E, Hofer M, Johnsson R, Ranstam J. Outcomes of endoscopic surgery compared with open surgery for carpal tunnel syndrome among employed patients: randomised controlled trial. BMJ. 2006 Jun 24;332(7556):1473. doi: 10.1136/bmj.38863.632789.1F. Epub 2006 Jun 15.
- Atroshi I, Hofer M, Larsson GU, Ranstam J. Extended Follow-up of a Randomized Clinical Trial of Open vs Endoscopic Release Surgery for Carpal Tunnel Syndrome. JAMA. 2015 Oct 6;314(13):1399-401. doi: 10.1001/jama.2015.12208. No abstract available.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2013
Primær fullføring (Faktiske)
1. november 2014
Studiet fullført (Faktiske)
1. januar 2015
Datoer for studieregistrering
Først innsendt
24. juni 2013
Først innsendt som oppfylte QC-kriteriene
25. juni 2013
Først lagt ut (Anslag)
26. juni 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
6. mai 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. mai 2015
Sist bekreftet
1. mai 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HLM-CTSRCT-2
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