Bi-trimalleolar Fracture and APOS System Treatment (APOS-IL 001)
This study is currently recruiting participants.
Verified March 2012 by Meir Medical Center
Sponsor:
Meir Medical Center
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01127776
First received: April 27, 2010
Last updated: March 16, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate of functional tests and clinical findings with APOS System treatment in patient after bi-trimalleolar fracture of ankle. These functional changes will be evaluated AOFS, FAOS, SF36 and WOMAC scores, walking laboratory GAITRite and clinical examination.
| Condition | Intervention | Phase |
|---|---|---|
|
Bi-trimalleolar Fracture of Ankle |
Device: APOS SYSTEM Other: APOS SYSTEM without biomechanics units. |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | APOS System Effects in Post-operation Bi-trimalleolar Fracture of Ankle Prospective, Comparative Randomize Trial Study |
Resource links provided by NLM:
Further study details as provided by Meir Medical Center:
Primary Outcome Measures:
- APOS System effects [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Evaluate with functional tests and clinical findings patient after bi-trimalleolar fracture of ankle with who recive APOS System treatment.
Functional changes will be evaluated using FAOS, SF36 and WOMAC scores, walking laboratory GAITRite and clinical examination.
Secondary Outcome Measures:
- Ankle fracture [ Time Frame: one year ] [ Designated as safety issue: Yes ]bi-trimalleolar ankle fracture - crif
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | May 2012 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Apos System |
Device: APOS SYSTEM
The trial group will receive APOS walking system The control group will receive the same walking protocol as the trial group without biomechanics units
|
| Placebo Comparator: CONTROL |
Other: APOS SYSTEM without biomechanics units.
The control group will receive the same walking protocol as the trial group without biomechanics units
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female patients 18-65 year old
- Post operation bi- trimalleolar fracture of ankle
- Download cast after 3 weeks
- Full Weight bearing after 6 weeks
- Patients in medical condition to receive physiotherapy treatment
- Patients who are willing to participate in the trial, to come to all scheduled visits and to sign the informed consent forms.
Exclusion Criteria:
- Patients suffering muscular or nerve disorders
- Patients who are unable to use the APOS SYSTEM and can not complete the experimental protocol due to physical or mental handicap
- Non cooperative patient with the basic rehab program.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127776
Locations
| Israel | |
| Orthopaedic Department - Meir Medical Center | Recruiting |
| Kfar - Saba, Israel | |
| Contact: Ezequiel Palmanovich, md ezepalm@gmail.com | |
Sponsors and Collaborators
Meir Medical Center
More Information
No publications provided
| Responsible Party: | Meir Medical Center |
| ClinicalTrials.gov Identifier: | NCT01127776 History of Changes |
| Other Study ID Numbers: | MMC9181-09CTIL |
| Study First Received: | April 27, 2010 |
| Last Updated: | March 16, 2012 |
| Health Authority: | United States: Institutional Review Board Israel: The Israel National Institute for Health Policy Research and Health Services Research Israel: Ethics Commission |
Keywords provided by Meir Medical Center:
|
patient after bi-trimalleolar fracture of ankle |
Additional relevant MeSH terms:
|
Fractures, Bone Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013