Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome
5 maj 2015 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
124
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
25 år till 60 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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.
Andra namn:
|
|
Experimentell: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change in CTS symptom severity score
Tidsram: Baseline to 10-15 years postoperatively
|
Baseline to 10-15 years postoperatively
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Rate of repeat surgery
Tidsram: 10-15 years postoperatively
|
10-15 years postoperatively
|
|
Change in CTS functional status score
Tidsram: 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
Tidsram: 10-15 years postoperatively
|
10-15 years postoperatively
|
|
Patient satisfaction with the results of surgery
Tidsram: 10-15 years postoperatively
|
10-15 years postoperatively
|
|
Change in CTS symptom severity score
Tidsram: 1 year to 10-15 years postoperatively
|
1 year to 10-15 years postoperatively
|
Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
|
CTS-6 score
Tidsram: 10-15 years postoperatively
|
10-15 years postoperatively
|
|
QuickDASH score
Tidsram: 10-15 years postoperatively
|
10-15 years postoperatively
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Isam Atroshi, MD, PhD, Clinical Sciences, Lund University, Sweden
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2013
Primärt slutförande (Faktisk)
1 november 2014
Avslutad studie (Faktisk)
1 januari 2015
Studieregistreringsdatum
Först inskickad
24 juni 2013
Först inskickad som uppfyllde QC-kriterierna
25 juni 2013
Första postat (Uppskatta)
26 juni 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
6 maj 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 maj 2015
Senast verifierad
1 maj 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HLM-CTSRCT-2
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