Narcotic ConsumptionPhase 4NCT00950183
Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures
A Phase 4 study testing Iceman® Cold Therapy unit (djOrtho) and Ice in people with Narcotic Consumption and Pain, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial summary
This study will compares differences in pain level, narcotic consumption, wound healing, patient satisfaction in patients randomized to the Iceman® cold pack therapy system (djOrtho, Inc) versus those who use ice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Narcotic Consumption, Pain, Wound Healing
- What is being tested?
- Iceman® Cold Therapy unit (djOrtho) and Ice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Dec 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who are scheduled to have either lateral ankle ligament reconstruction (LAR) surgery or primary first metatarsal osteotomy surgery
- Patients who agree to be compliant and to keep a patient diary daily for 2 weeks and to return to the clinic for a 2 week postoperative follow- up appointment
Who cannot join
- Patients with Diabetes Mellitus, peripheral vascular disease, Reynauds Syndrome, hypersensitivity to cold
- Patients allergic to hydrocodone or oxycodone
- Patients who are unwilling to complete the patient diary and/or follow their specific cold therapy instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures: An Evaluation of Narcotic Consumption, Pain, Wound Healing, and Patient Satisfaction
This study will compares differences in pain level, narcotic consumption, wound healing, patient satisfaction in patients randomized to the Iceman® cold pack therapy system (djOrtho, Inc) versus those who use ice. This will be assessed postoperatively following the foot and ankle procedures primary first metatarsal osteotomy (PMO) or lateral ankle ligament reconstruction (LAR).
- Conditions
- Narcotic Consumption, Pain, Wound Healing, Patient Satisfaction
- Being tested
- Iceman® Cold Therapy unit (djOrtho), Ice
- Keywords
- cryotherapy, postoperative pain, Iceman, primary first metatarsal osteotomy (PMO), lateral ankle ligament reconstruction (LAR)
- Medical subject headings
- Pain, Patient Satisfaction, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iceman® Cold Therapy unit (djOrtho)Device
postoperative cold therapy
IceOther
postoperative cold therapy
| Study group | Role | What they receive |
|---|---|---|
| Foot and Ankle Surgery | Other | Please note that the study was terminated prior to randomization of patients. Receives: Device: Iceman® Cold Therapy unit (djOrtho); Other: Ice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Pain Scores
Measured: postop day 1 up to postop day 14
Secondary outcomes (4)
Narcotic Pain Medication Usage
Measured: postop day 1 up to postop day 14
Patient Satisfaction
Measured: first postoperative visit (between postop day 10 and 14)
Surgical Complications
Measured: Day of Surgery
Postoperative Complications
Measured: postop day 1 up to postop day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startFeb 2007
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: recruitment feasability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Narcotic ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- DJO Incorporated
- Responsible party
- Sponsor
- Investigators
- Robert B Anderson, MD, Principal investigator, OrthoCarolina, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950183
- Sponsor's protocol ID
- 020723E
- Status last verified
- Oct 2014
- First submitted
- 29 Jul 2009
- Last updated
- 22 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures: An Evaluation of Narcotic Consumption, Pain, Wound Healing, and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT00950183
- Acronym / sponsor ID
- 020723E
- Conditions
- Narcotic Consumption, Pain, Wound Healing, Patient Satisfaction
- Keywords
- cryotherapy, postoperative pain, Iceman, primary first metatarsal osteotomy (PMO), lateral ankle ligament reconstruction (LAR)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment feasability
- Enrolment
- 36 participants (actual)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Collaborators
- DJO Incorporated
- Study start
- Feb 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 31 Jul 2009 (estimated)
- Results
- Posted 4 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compares differences in pain level, narcotic consumption, wound healing, patient satisfaction in patients randomized to the Iceman® cold pack therapy system (djOrtho, Inc) versus those who use ice. This will be assessed postoperatively following the foot and ankle procedures primary first metatarsal osteotomy (PMO) or lateral ankle ligament reconstruction (LAR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foot and Ankle Surgery | Other | Device: Iceman® Cold Therapy unit (djOrtho), Other: IcePlease note that the study was terminated prior to randomization of patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are scheduled to have either lateral ankle ligament reconstruction (LAR) surgery or primary first metatarsal osteotomy surgery
- Patients who agree to be compliant and to keep a patient diary daily for 2 weeks and to return to the clinic for a 2 week postoperative follow- up appointment
Key exclusion criteria (3 listed)
- Patients with Diabetes Mellitus, peripheral vascular disease, Reynauds Syndrome, hypersensitivity to cold
- Patients allergic to hydrocodone or oxycodone
- Patients who are unwilling to complete the patient diary and/or follow their specific cold therapy instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iceman® Cold Therapy unit (djOrtho)postoperative cold therapy | Device | Foot and Ankle Surgery |
| Icepostoperative cold therapy | Other | Foot and Ankle Surgery |
Primary outcome
Visual Analog Scale (VAS) Pain Scores
Time frame: postop day 1 up to postop day 14
4 secondary outcomes
Narcotic Pain Medication Usage
Time frame: postop day 1 up to postop day 14
Patient Satisfaction
Time frame: first postoperative visit (between postop day 10 and 14)
Surgical Complications
Time frame: Day of Surgery
Postoperative Complications
Time frame: postop day 1 up to postop day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert B Anderson, MD principal investigator
OrthoCarolina, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iceman® Cold Therapy unit (djOrtho) and Ice in people with Narcotic Consumption and Pain, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Pain Scores (time frame: postop day 1 up to postop day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.