Transtibial AmputationNCT00263497
Temporary Prosthesis in Traumatic Below-knee Amputation
A study testing Temporary tuber-ischii bearing prosthesis in people with Transtibial Amputation, run by University Hospital of North Norway at 1 site in Cambodia.
Trial summary
Most trauma survivors in low-income countries develop post-injury chronic pain syndromes. Normally traumatic amputees have to wait 4-6 months for definitive prosthesis fitting. The actual study aims at reducing post-injury chronic pain and improving function by immediate temporary prosthesis fitting after surgery. Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Transtibial Amputation
- What is being tested?
- Temporary tuber-ischii bearing prosthesis
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteCambodia
- Study dates
- Mar 2006to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Traumatic transtibial amputation
Who cannot join
- Double amputation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Temporary Prosthesis Fitting in Traumatic Trans-tibial Amputation: a Controlled Clinical Study in Rural Cambodia
Most trauma survivors in low-income countries develop post-injury chronic pain syndromes. Normally traumatic amputees have to wait 4-6 months for definitive prosthesis fitting. The actual study aims at reducing post-injury chronic pain and improving function by immediate temporary prosthesis fitting after surgery.
Read the detailed description
Background: Previous studies document that 75% of traumatic amputees in low-income countries develop incapacitating chronic pain syndromes. With the present level of rehabilitation service, amputees have to wait 4-6 months for postoperative prosthesis fitting.
Hypothesis: Immediate postoperative prosthesis fitting reduce chronic pain and improves function in trans-tibial amputees.
Reference population: Traumatic amputees living in low-income and low-resource communities.
Study population: Adult patients with trans-tibial amputations in rural districts of Battambang Province, Cambodia.
Study design: A semi-cross over controlled study. Supplement:longitudinal qualitative studies of subsets.
Main variables for quantitative study:
- Outcome indicators:Self-rated pain (VAS). Self-rated function (VAS). Pain (clinical exam). Gait analysis.
- Variables: Preinjury morbidity and socioeconomical status. Injury severity (RTS, ISS). Prehospital and hospital analgesia. Postoperative infection. Amputation stump quality (clinical rating).
Sampling: Given test power =0.8, significance level =0.05, sequential analysis of results, an estimate of 15 patients will be included in each study group. The sample may be modified due to sequential analysis (see below).
Intervention: A mobile rural workshop takes molds and adapt temporary tuber-ischii bearing prosthesis made of local materials. The prosthesis is fitted at the time of amputation wound closure (5 - 15 days post-injury), and patients mobilized on walking aids. Control group patients comprise of transtibial amputees managed at neighboring hospitals not being served by the actual rehab workshop. Control patients leave hospital with walking aids without prosthesis. Data are gathered by rehab team (surgeon and prosthesis technician) at point zero, 1 month postoperation, 3 months postoperation. End-point for evaluation is 6 months post-op. Patients decide freely to cross-over on pain indications.
Statistical analysis: Sequential design with positive and negative stopping rules. Outcome variables at end-point are reported for groups of 3 patients to statistician(Prof. Stig Larsen, University of Oslo) who gives stop orders.
Ethical considerations: If ITP proves favorable, the study results will be used to expand the rural rehab service to include control districts as well. This makes the use of control groups in the actual study legitimate. Also optional cross-over prevents against inflicting unnecessary discomfort in study patients. The study is approved by the local health authorities and Norwegian Committee for Research Ethics. The system for data filing and protection is approved by Norwegian Social Science Data Services, Bergen.
Publication: Authorship will be set according to Vancouver regulations.
- Conditions
- Transtibial Amputation
- Being tested
- Temporary tuber-ischii bearing prosthesis
- Keywords
- Postinjury chronic pain, Transtibial amputation, Physical rehabilitation, Immediate temporary prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary tuber-ischii bearing prosthesisDevice
Tuber ischii-bearing holster is connected by hinged metal bars to foot device to enable immediate postoperative mobilization of transtibial amputees. No other medical interventions or pharmaceutical treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain: Patient-rated
Measured: 1, 3, and 6 months postinjury
Pain: clinical exam rated
Measured: 1, 3, and 6 months post-injury
Function: patient-rated
Measured: 1, 3, and 6 months post-injury
Function: gait analysis
Measured: 1, 3, and 6 months post-injury
Secondary outcomes (1)
Qualitative longitudinal study of subsets
Measured: 1, 3, and 6 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2005 (estimated)
- Study startMar 2006
- Primary completionMar 2020
- Study completionMar 2020
Why it stopped: No update for several year, confermed ended by Odd Edvardsen i march 2020.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transtibial AmputationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Joenkoeping, Sweden, NCHADS - Ministry of Health of Cambodia
- Responsible party
- Sponsor
- Investigators
- Bjoern Karlsson, Rehab Ing, Principal investigator, TMC, University Hospital Northern Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263497
- Sponsor's protocol ID
- KHM1030375
- Status last verified
- Mar 2020
- First submitted
- 7 Dec 2005
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Temporary Prosthesis Fitting in Traumatic Trans-tibial Amputation: a Controlled Clinical Study in Rural Cambodia
- ClinicalTrials.gov ID
- NCT00263497
- Acronym / sponsor ID
- KHM1030375
- Conditions
- Transtibial Amputation
- Keywords
- Postinjury chronic pain, Transtibial amputation, Physical rehabilitation, Immediate temporary prosthesis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No update for several year, confermed ended by Odd Edvardsen i march 2020.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Medical University of Joenkoeping, Sweden, NCHADS - Ministry of Health of Cambodia
- Study start
- Mar 2006
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 8 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most trauma survivors in low-income countries develop post-injury chronic pain syndromes. Normally traumatic amputees have to wait 4-6 months for definitive prosthesis fitting. The actual study aims at reducing post-injury chronic pain and improving function by immediate temporary prosthesis fitting after surgery.
Detailed description
Background: Previous studies document that 75% of traumatic amputees in low-income countries develop incapacitating chronic pain syndromes. With the present level of rehabilitation service, amputees have to wait 4-6 months for postoperative prosthesis fitting.
Hypothesis: Immediate postoperative prosthesis fitting reduce chronic pain and improves function in trans-tibial amputees.
Reference population: Traumatic amputees living in low-income and low-resource communities.
Study population: Adult patients with trans-tibial amputations in rural districts of Battambang Province, Cambodia.
Study design: A semi-cross over controlled study. Supplement:longitudinal qualitative studies of subsets.
Main variables for quantitative study:
- Outcome indicators:Self-rated pain (VAS). Self-rated function (VAS). Pain (clinical exam). Gait analysis.
- Variables: Preinjury morbidity and socioeconomical status. Injury severity (RTS, ISS). Prehospital and hospital analgesia. Postoperative infection. Amputation stump quality (clinical rating).
Sampling: Given test power =0.8, significance level =0.05, sequential analysis of results, an estimate of 15 patients will be included in each study group. The sample may be modified due to sequential analysis (see below).
Intervention: A mobile rural workshop takes molds and adapt temporary tuber-ischii bearing prosthesis made of local materials. The prosthesis is fitted at the time of amputation wound closure (5 - 15 days post-injury), and patients mobilized on walking aids. Control group patients comprise of transtibial amputees managed at neighboring hospitals not being served by the actual rehab workshop. Control patients leave hospital with walking aids without prosthesis. Data are gathered by rehab team (surgeon and prosthesis technician) at point zero, 1 month postoperation, 3 months postoperation. End-point for evaluation is 6 months post-op. Patients decide freely to cross-over on pain indications.
Statistical analysis: Sequential design with positive and negative stopping rules. Outcome variables at end-point are reported for groups of 3 patients to statistician(Prof. Stig Larsen, University of Oslo) who gives stop orders.
Ethical considerations: If ITP proves favorable, the study results will be used to expand the rural rehab service to include control districts as well. This makes the use of control groups in the actual study legitimate. Also optional cross-over prevents against inflicting unnecessary discomfort in study patients. The study is approved by the local health authorities and Norwegian Committee for Research Ethics. The system for data filing and protection is approved by Norwegian Social Science Data Services, Bergen.
Publication: Authorship will be set according to Vancouver regulations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Traumatic transtibial amputation
Key exclusion criteria (1 listed)
- Double amputation
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 |
|---|---|---|
| Temporary tuber-ischii bearing prosthesisTuber ischii-bearing holster is connected by hinged metal bars to foot device to enable immediate postoperative mobilization of transtibial amputees. No other medical interventions or pharmaceutical treatment. | Device | – |
Primary outcome
Pain: Patient-rated
Time frame: 1, 3, and 6 months postinjury
Pain: clinical exam rated
Time frame: 1, 3, and 6 months post-injury
Function: patient-rated
Time frame: 1, 3, and 6 months post-injury
Function: gait analysis
Time frame: 1, 3, and 6 months post-injury
1 secondary outcome
Qualitative longitudinal study of subsets
Time frame: 1, 3, and 6 months post-injury
Results and safety
The study was stopped early (reason given: No update for several year, confermed ended by Odd Edvardsen i march 2020.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
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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.
Bjoern Karlsson, Rehab Ing principal investigator
TMC, University Hospital Northern Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary tuber-ischii bearing prosthesis in people with Transtibial Amputation, run by University Hospital of North Norway at 1 site in Cambodia.
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 1 inclusion and 1 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 10 Mar 2020. 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 Cambodia. 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.
Are results available for this study?
The study was stopped early (reason given: No update for several year, confermed ended by Odd Edvardsen i march 2020.). Results are not available in the source record.
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?
Pain: Patient-rated (time frame: 1, 3, and 6 months postinjury). The study lists 4 primary outcomes in all. 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 10 Mar 2020.