Umiddelbar mobilisering versus 2 uker støpt immobilisering etter distal radiusbrudd behandlet med volar låseplate (LIMPER-DRF)
Umiddelbar mobilisering versus 2 uker støpt immobilisering etter distal radiusfraktur behandlet med volar låseplate - en studieprotokoll for en prospektiv, randomisert, kontrollert prøvelse
The aim of this study is to analyze total lenght of the sick leace and functional outcome (PRWE) at 2 months between 2 weeks casting and immediate mobilization following volar plating for a DRF.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study is a prospective, randomized, controlled trial. The aim of this study will be to compare the early postoperative outcomes of the patients enrolled in the early mobilization with those patients in post-operative 2-week casting following volar plating for a DRF. Co-primary outcome in this study will be the total lenght of sick leave and Patient-Rated Wrist Evaluation (PRWE) 2 months after the operation.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Intra- or extra articular DRF (Colles, Smith, Volar barton)
- operative treatment justified
Exclusion Criteria:
- Refusal to participate in the study
- Open fracture with a severity greater than Gustilo grade 1
- Patient aged less than 18 or over 65
- Patient does not understand written or spoken guidance in local languages
- Pathological fracture
- Previous fracture in the same wrist or forearm in the last 10 years, that has led to impairment of function
- Ipsilateral fracture in upper extremity
- Associated fractures of the ulna (except fractures of the PSU)
- Polytrauma
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: Umiddelbar mobilisering etter distal radiusfraktur behandlet med volar låseplate
|
Immediate mobilization postoperatively without casting Volar plating of distal radius fracture |
|
Aktiv komparator: 2 uker gipsimmobilisering etter distal radiusfraktur behandlet med volar låseplate
|
Volar plating of distal radius fracture Dorsal cast placed in OR |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient-rated wrist evaluation questionnaire
Tidsramme: 2 months
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
2 months
|
|
Total lenght of the sick leave
Tidsramme: 12 months
|
Total number of days of work during the 1 year study period |
12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient-rated wrist evaluation questionnaire
Tidsramme: 4 weeks
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
4 weeks
|
|
Patient-rated wrist evaluation questionnaire
Tidsramme: 6 months
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
6 months
|
|
Patient-rated wrist evaluation questionnaire
Tidsramme: 12 months
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
12 months
|
|
Return to work
Tidsramme: 4 weeks
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
4 weeks
|
|
Return to work
Tidsramme: 2 months
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
2 months
|
|
Return to work
Tidsramme: 6 months
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
6 months
|
|
Return to work
Tidsramme: 12 months
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
12 months
|
|
Complications
Tidsramme: 4 weeks
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
4 weeks
|
|
Complications
Tidsramme: 2 months
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
2 months
|
|
Complications
Tidsramme: 6 months
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
6 months
|
|
Complications
Tidsramme: 12 months
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
12 months
|
|
Self-perceived working ability
Tidsramme: 4 weeks
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
4 weeks
|
|
Self-perceived working ability
Tidsramme: 2 months
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
2 months
|
|
Self-perceived working ability
Tidsramme: 6 months
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
6 months
|
|
Self-perceived working ability
Tidsramme: 12 months
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
12 months
|
|
Visual analogue pain scale
Tidsramme: 4 weeks
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
4 weeks
|
|
Visual analogue pain scale
Tidsramme: 2 months
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
2 months
|
|
Visual analogue pain scale
Tidsramme: 6 months
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
6 months
|
|
Visual analogue pain scale
Tidsramme: 12 months
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
12 months
|
|
Patient-acceptable symptom state
Tidsramme: 2 months
|
Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)? |
2 months
|
|
Patient-acceptable symptom state
Tidsramme: 6 months
|
Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)? |
6 months
|
|
Patient-acceptable symptom state
Tidsramme: 12 months
|
Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)? |
12 months
|
|
Work capacity
Tidsramme: 4 weeks
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
4 weeks
|
|
Work capacity
Tidsramme: 2 months
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
2 months
|
|
Work capacity
Tidsramme: 6 months
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
6 months
|
|
Work capacity
Tidsramme: 12 months
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
12 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient activity
Tidsramme: 4 weeks
|
Patient activity measured with triaxial wrist accelerometer |
4 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Aleksi Reito, Tampere University Hospital
- Hovedetterforsker: Laura Kärnä, MD, Tampere University Hospital
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R21111
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Data is available on reasonable request.
IPD-delingstidsramme
After the study has been completed and for 10 years after.
Tilgangskriterier for IPD-deling
On reasonable request and research plan for IPD use should be provided.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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