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NCT03789435: AMPUPHANTOM
Pain in Trans Femoral and Trans Tibial Amputees
trial testing Questionnaire in Lower Limb Amputation Above Knee in 73 participants. Completed in 30 September 2019.
31 August 2019
Quick facts
| Lead sponsor | Istituto Ortopedico Rizzoli |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 73 |
| Start date | 7 March 2019 |
| Primary completion | 31 August 2019 |
| Estimated completion | 30 September 2019 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Questionnaire
Conditions studied
- Lower Limb Amputation Above Knee — all drugs for Lower Limb Amputation Above Knee →
- Lower Limb Amputation Below Knee — all drugs for Lower Limb Amputation Below Knee →
Sponsor
Istituto Ortopedico Rizzoli — full company profile →
Who can join
18 and older, any sex, with Lower Limb Amputation Above Knee or Lower Limb Amputation Below Knee. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Phantom limb is difficult to manage and has a significant impact on the patient's quality of life. At present, the scientific evidence shows that the infusion of local anesthetics with epidural and perineural catheters in the perioperative phase correlates with good pain control in the immediate post-operative, expressed in terms of reduced demand for opiates by the patient undergoing amputation. of lower limb. Few are studies that highlight the effectiveness of such treatments in the medium and long-term prevention of phantom limb syndrome. The study aims to evaluate the incidence in the medium term of the phantom limb in trans femoral and trans tibial amputees and the possible relationship with the use of adequate pre and perioperative analgesia using peridural and peripheral nerve catheters. The results of the study could provide indications about the need to modify both the perioperative analgesic therapy protocol and also rehabilitation for lower limb amputation surgery in order to reduce the prevalence of phantom limb syndrome with consequent improvement in quality of life.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03789435
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Lower Limb Amputation Above Knee
Currently open trials in the same condition.
- NCT07214493 — Study on a Prosthetic Foot With Adjustable Heel Height · NA · recruiting
- NCT07324109 — Clinical Application Observation on the Evaluation of Phantom Limb Pain With the Suralis System · NA · recruiting
Other Istituto Ortopedico Rizzoli trials
Trials by the same sponsor.
- NCT07590882 — Evaluation of Return to Sports Activity After Periacetabular Osteotomy: An Observational Study · enrolling by invitation
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- NCT07360964 — Clear Cell Chondrosarcoma in Italy · NA · active not recruiting
- NCT07140367 — "Transarterial Microembolization (TAME) in Inflammatory Knee Pathology" · recruiting
- NCT07102875 — Ready to Sail 2: A Pilot Study of Sail-Assisted Telerehabilitation in Rare Skeletal Diseases · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03789435 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituto Ortopedico Rizzoli
- Last refreshed: 13 January 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03789435.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing