Press-Fit vs Loose-Fit Radial Head Arthroplasty
NCT07932704, Not applicable, Recruiting, AdventHealth
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Press-Fit vs Loose-Fit Radial Head Arthroplasty | ClinicalTrials.gov |
| NCT number | NCT07932704 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 130 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | AdventHealth | ClinicalTrials.gov |
| Conditions | Radial Head Fractures, Elbow Fractures, Elbow Dislocation, Elbow Injuries and Disorders | ClinicalTrials.gov |
| Interventions | Skeletal Dynamics Radial Head (Press-Fit), Stryker Radial Head (Loose-Fit). | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Elbow Flexion-Extension Arc of Motion | Baseline, 3 months, 6 months, 12 months, and 24 months postoperatively | Total arc of elbow flexion-extension in degrees (maximum flexion minus loss of extension), measured with a goniometer. The primary comparison between groups is at 24 months postoperatively. Measurements at earlier time points are reported to describe recovery over time. | ClinicalTrials.gov |
| Secondary | Forearm Rotation Arc of Motion | Baseline, 3, 6, 12, and 24 months postoperatively | Total arc of forearm rotation in degrees (maximum pronation plus maximum supination), measured with a goniometer. | ClinicalTrials.gov |
| Secondary | Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score | Baseline (preoperative), 3, 6, 12, and 24 months postoperatively | The QuickDASH is an 11-item patient-reported questionnaire assessing upper extremity function and symptoms. Scores range from 0 to 100, and higher scores indicate greater disability (worse outcome). | ClinicalTrials.gov |
| Secondary | Mayo Elbow Performance Score (MEPS) | Baseline (preoperative), 3, 6, 12, and 24 months postoperatively | The MEPS assesses elbow pain, range of motion, stability, and ability to perform daily activities. Scores range from 0 to 100, and higher scores indicate better elbow function (better outcome). | ClinicalTrials.gov |
| Secondary | Visual Analog Scale (VAS) for Pain | Baseline, 3, 6, 12, and 24 months postoperatively | Participants mark their pain intensity on a continuous line scored from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain. | ClinicalTrials.gov |
| Secondary | Number of Participants Receiving Corticosteroid Injections | Through 24 months postoperatively | Number of participants who receive one or more corticosteroid injections to the operative elbow after radial head arthroplasty. | ClinicalTrials.gov |
| Secondary | Number of Participants Requiring Reoperation | Through 24 months postoperatively | Number of participants who undergo any secondary surgical procedure on the operative elbow after the index radial head arthroplasty, including stiffness release and implant removal. | ClinicalTrials.gov |
| Secondary | Number of Participants With Radiographic Implant Loosening | Through 24 months postoperatively | Intramedullary stem loosening on standard elbow radiographs. | ClinicalTrials.gov |
| Secondary | Number of Participants With Radiographic Implant Subsidence | Through 24 months postoperatively | Implant subsidence on standard elbow radiographs compared with immediate postoperative radiographs. | ClinicalTrials.gov |
| Secondary | Number of Participants With Radial Neck Resorption | Through 24 months postoperatively | Radial neck bone resorption (stress shielding) on standard elbow radiographs. | ClinicalTrials.gov |
| Secondary | Number of Participants With Heterotopic Ossification | Through 24 months postoperatively | Heterotopic ossification on standard elbow radiographs. | ClinicalTrials.gov |
| Secondary | Number of Participants With Surgical or Implant-Related Complications | Through 24 months postoperatively | Number of participants with one or more complications related to the surgery or implant, including implant loosening, infection, stiffness, nerve injury, instability, or implant failure. | ClinicalTrials.gov |
| Secondary | Grip Strength | 3, 6, 12, and 24 months postoperatively | Maximum grip strength of the operative hand in kilograms, measured with a hand-held dynamometer. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)