Trial · NCT04874870
Effectiveness of Splinting After Collagenase Injection
NCT04874870, Phase 3, Completed, Foundation for Orthopaedic Research and Education
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effectiveness of Splinting After Collagenase Injection. Trials, record NCT04874870. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04874870
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness of Splinting After Collagenase Injection
- NCT number
- NCT04874870
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 80 participants, actual
- Lead sponsor
- Foundation for Orthopaedic Research and Education
- Conditions
- Dupuytren Contracture, Dupuytren's Disease
- Interventions
- Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex], Xiaflex + Hand-Based Custom Orthosis
- First posted
- 2021-05-06
- Last updated
- 2025-02-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Improvement in active extension deficit of MCP joint, in degrees, if applicable | Baseline, 1 month, and 4 months | Clinical measurement of MCP joint extension with goniometer, in degrees, of treated finger |
| Primary | Improvement in active extension deficit of PIP joint, in degrees, if applicable | Baseline, 1 month, and 4 months | Clinical measurement of PIP joint extension with goniometer, in degrees, of treated finger |
| Primary | Improvement in total active extension of each digit, in degrees | Baseline, 1 month, and 4 months | Sum of MCP and PIP joint extension, in degrees, of treated finger |
| Secondary | Compliance of Splint wearing (Splint group only) | 1 month and 4 months | By compliance survey composed of 4 items Items 1 and 2 scored from 1-5; 1 - not at all, 2 - slightly, 3- moderately, 4- very, 5- extremely How comfortable was your splint? Was the splint easy to use? Items 3 and 4 scored from 1-5; 1 - not at all, 2 - occasionally, 3- half of the time, 4 - most of the time, 5 - all of the time Did you wear your splint every night? Did you have any issues with your splint? |
| Secondary | Functional Outcomes | Baseline, 1 month, and 4 months | Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire score will be used to measure clinical outcomes. The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (four items, scored 1-5). From the item scores, scale scores are calculated, ranging from 0 (no disability) to 100 (most severe disability). |
| Secondary | Patient Satisfaction | 1 month and 4 months | By satisfaction scale composed of 3 items (each of them scored from 1-5; 1 - not at all, 2 - slightly, 3- moderately, 4- very, 5- extremely) How satisfied are you with the progress of your hand? How satisfied are you with your treatment? Has your quality of life improved? |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04874870
GET https://conductscience.org/api/trials/v1/NCT04874870/registered