Trial · NCT03192020
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of success | 5 year follow-ups | Success is a composite outcome comprising of 1) at least 50% contracture release from the recruitment and 2) patient is in patient accepted symptom state (PASS). PASS is defined by question: "Would you be satisfied and not in need for any other treatment if the functional impairment caused by the contracture would remain the same as it is today for the rest of your life?". Primary time point is five years' follow-up visit. |
| Secondary | QuickDASH | 3 months, 2, 5 and 10 year follow-ups | QuickDASH questionnaire is a validated upper extremity specific questionnaire consisting of 11 tasks/questions about the functional capacity and the pain. |
| Secondary | Perceived hand function | 3 months, 2, 5 and 10 year follow-ups | Perceived hand function will be assessed pre- and postoperatively by VAS scale. |
| Secondary | Global rating | 3 months, 2, 5 and 10 year follow-ups | Global rating to treatment effect will be evaluated by question: "How would you rate the function of your hand compared to the situation before the treatment?". The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better: This question is also used as anchor question in the MCII analysis in which +1 and +2 are considered to present meaningful improvement to the patient. |
| Secondary | EQ-5D-3L | 3 months, 2, 5 and 10 year follow-ups | EQ-5D-3L is a generic instrument for assessing quality of life comprising 5 dimensions and VAS for health level. |
| Secondary | Rate of Patient Accepted Symptom State | 3 months, 2, 5 and 10 year follow-ups | PASS is a relevant patient-centered outcome measurement, which reflects the overall state in which patients consider themselves as being well. It is a state of the symptoms between complete remission and subjective dissatisfaction with the symptoms. |
| Secondary | Rate of patients achieving clinically significant improvement | 10 year follow-up | Percentage of patients achieving clinically significant improvement (50% better PED) will be assessed. |
| Secondary | Rate of patients achieving full contracture release | 3 months, 2, 5 and 10 year follow-ups | Percentage of patients achieving full contracture release (PED 0°-5°) will be assessed. |
| Secondary | Willingness to undergo same treatment | 3 months and 2 year follow-ups | Patient satisfaction with the treatment will be assessed by a simple "yes" or "no" question: "Would you prefer the same treatment again, if the result would be the same as it is now?" |
| Secondary | Major adverse events | 3 months, 2, 5 and 10 year follow-ups | In the trial will be reported major adverse events, which include: tendon rupture, nerve injury, arterial injury, CRPS and infection, skin rupture or hematoma that needs hospitalization/revision surgery. |
| Secondary | Extension deficits | 3 months, 2, 5 and 10 year follow-ups | The total passive extension deficit (TPED) and passive extension deficit (PED) of metacarpophalangeal (MPJ) and proximal interphalangeal (PIPJ) joints are used in almost all of the DC studies. Most of the studies used the PED as their primary outcome. In this trial, the TPED and PED of MPJ and PIPJ are used as secondary outcomes. |
| Secondary | Total maximum flexion | 3 months, 2, 5 and 10 year follow-ups | Patients are seeking help for their extension deficit in DC but in the end flexion of the fingers is more important for the hand function. Our treatments should not jeopardize finger flexion in an effort to reduce the extension deficit. |
| Secondary | Expenses | 2, 5 and 10 year follow-ups | The costs are assessed by allocating previously estimated costs for interventions to each of the treatment arm. |
| Secondary | Progression of the disease | 2, 5 and 10 year follow-ups | Recurrence or extension is treated if the patient contacts the study center and requires new treatment (ie, patient is not in the PASS anymore) and at least 20° flexion contracture is observed in one of the joints. Progression of disease is measured and reported in three levels: (1) rate of reinterventions in the arm due to recurrence or extension of the disease (clinically relevant progression); (2) costs of reinterventions (impact of progression); and (3) change in TPED in those patients who do not require further treatments (clinically irrelevant progression). |
| Secondary | Recurrence of the disease | 2, 5 and 10 year follow-ups | In this study recurrence is defined when patient considers not being in PASS anymore and seeks for further treatment, and has at least 20° contracture. |
| Secondary | Extension of the disease | 2, 5 and 10 year follow-ups | Extension means that the disease will be activated in other rays than treated after the treatment. |
| Secondary | Progression-free-survival | 2, 5 and 10 year follow-ups | Progression-free-survival will be counted to each arm as mean time. |
| Secondary | Favored treatment modality questionnaire | 2, 5 and 10 year follow-ups | Favored treatment modality will be asked from patients who undergo several treatment modalities (i.e. LF after CCH or PNF). Outcome will be assessed by question: "If you presented with a contracture for the first time now, would you prefer needle fasciotomy/injectable drug as the primary treatment or would prefer having surgery at first place?" |
| Secondary | Rate of success | 3 months, 2 and 10 year follow-ups | Success is a composite outcome comprising of 1) at least 50% contracture release from the recruitment and 2) patient is in patient accepted symptom state (PASS). PASS is defined by question: "Would you be satisfied and not in need for any other treatment if the functional impairment caused by the contracture would remain the same as it is today for the rest of your life?". Primary time point is five years' follow-up visit. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03192020/registered