Comparative Study of Four- and Six-Strand Flexor Tendon Repair in Zone II (FLEXSTRAND)
Comparison of Six Strand and Four Strand Techniques on the Repair of Injured Flexor Tendons of Zone II of the Hand
Flexor tendon injuries in Zone 2 of the hand remain challenging because of the need to achieve optimal tendon healing while allowing early mobilization and minimizing complications such as rupture and adhesions. Various tendon repair techniques have been described, including four-strand and six-strand core suture methods.
This study aims to compare the functional outcomes and complication rates between four-strand and six-strand flexor tendon repair techniques in patients with Zone 2 flexor tendon injuries.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Flexor tendon injuries of Zone 2 are among the most difficult hand injuries to manage because of the complex anatomy and the tendency for adhesion formation and tendon rupture. Advances in tendon repair techniques have focused on increasing repair strength to permit early active mobilization while maintaining tendon gliding.
Four-strand repair techniques have been widely used and provide acceptable tensile strength and clinical outcomes. However, six-strand repair techniques may provide greater biomechanical stability and potentially allow safer early mobilization with lower rupture rates. Despite these theoretical advantages, there remains ongoing debate regarding the superiority of one technique over the other in terms of functional recovery and complication profile.
This prospective comparative study will be conducted in patients presenting with acute Zone 2 flexor tendon injuries of the hand. Eligible patients will undergo tendon repair using either four-strand or six-strand core suture techniques according to study allocation. All patients will follow a standardized postoperative rehabilitation protocol.
Primary outcomes will include functional assessment using total active motion and tendon rupture rates.
The findings of this study may help determine the optimal repair technique for improving functional outcomes in Zone 2 flexor tendon injuries while minimizing complications.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Punjab Province
-
Faisalabad, Punjab Province, Pakistan, 00000
- Allied Hospital, Faisalabad Medical University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Male or female participants.
- Age 18 to 50 years.
- Zone II flexor tendon injury of the hand.
- Presentation within one week of injury.
- Willingness to participate and provide informed consent.
- Ability to comply with the postoperative rehabilitation protocol.
Exclusion Criteria:
- Injuries that interfere with postoperative rehabilitation.
- Extensive soft tissue damage associated with the tendon injury.
- Previous tendon injury in the same digit or hand region.
- Previous surgery in the same affected area.
- Non-compliance or anticipated inability to comply with the postoperative rehabilitation protocol.
- Evidence of a psychological or personality disorder that may affect participation or outcome assessment.
- Systemic illness that may compromise wound or tendon healing (e.g., uncontrolled diabetes mellitus, connective tissue disorders, severe vascular disease).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Four strand repair group
Participants in this group will undergo repair of Zone 2 flexor tendon injuries using the four-strand core suture tendon repair technique followed by standardized postoperative rehabilitation.
|
Repair of Zone 2 flexor tendon injuries using a four-strand core suture tendon repair technique performed under standard operative protocol followed by postoperative rehabilitation.
|
|
Eksperimentell: Six strand repair group
Participants in this group will undergo repair of Zone 2 flexor tendon injuries using the six-strand core suture tendon repair technique followed by standardized postoperative rehabilitation.
|
Repair of Zone 2 flexor tendon injuries using a six-strand core suture tendon repair technique performed under standard operative protocol followed by postoperative rehabilitation.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional Outcome according to Tang Criteria
Tidsramme: Three months after Tendon repair
|
Functional outcome assessed using the Tang classification (Excellent, Good, Fair, Poor) based on total active motion of the injured finger.
The higher the Tang score, the better functional outcome.
|
Three months after Tendon repair
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- No.48.ERC/FMU/2025-26/106
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .