Clinical trial · Interventional
Dynamic ROM Via Gait Analysis and 3D Fluoroscopy in THA With Different Head Diameters
Dynamic Range of Motion (ROM) Assessment Using Gait Analysis and Three-dimensional Fluoroscopy in Patients Treated by Total Hip Arthroplasty (THA) With Different Head Diameters
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Pain and reduced function are the most common symptoms of coxarthritis. Pain relief and normal range of motion (ROM) restoration are the objectives of a Total Hip Arthroplasty (THA) procedure. It is recognized that increased head-neck ratio results in increased ROM due to the fact that prosthetic impingement between neck and acetabular liner occurs with wider arcs of motion. This head-neck ratio has been investigated extensively only in vitro (on cadavers or sawbones) or using mathematical modeling in computer simulations. These studies are limited by the lack of soft tissues and muscle activations in the models. This study will clinically assess the effect of prosthetic head diameter on patient capability of performing movements which require extreme arcs of motion of the hip joint. Therefore, the research questions are: * What role do soft tissues play in limiting ROM? * Can prosthetic impingement really occur in a well positioned THA? * Can a bigger head diameter alone reduce the risk of impingement?
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hip Osteoarthritis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| THA Corail DeltaMotion36 | Device | — | UNRESOLVED |
| THA Corail DeltaMotion40 | Device | — | UNRESOLVED |
| THA Corail PinnacleCoC28 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- THA28
- description
- THA Corail PinnacleCoC28
- interventionNames
- Device: THA Corail PinnacleCoC28
- type
- ACTIVE_COMPARATOR
- label
- THA36
- description
- THA Corail DeltaMotion36
- interventionNames
- Device: THA Corail DeltaMotion36
- type
- ACTIVE_COMPARATOR
- label
- THA40
- description
- THA Corail DeltaMotion40
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with unilateral primary or secondary hip arthrosis indicated for THA; * Men and female, age between 35 and 55 years old; * BMI smaller than 30; * Patients able to understand the protocol and to sign the informed consent. Exclusion Criteria: * Child-bearing female; * Patients with also controlateral hip arthritis; * Neurological patients, because of possible alteration of neuro-muscular control of the replaced hip; * Patients treated with joint replacement at any other lower limb articulation
References
Publications (0)
Data not yet available