Cerebral PalsyNCT02075853
Outcomes of the Evans Calcaneal Lengthening Based on Bone Grafting Material
An observational study of Cerebral Palsy and Pes Planus, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The Evans calcaneal lengthening is a common surgical correction used for children with spastic cerebral palsy (CP) and painful flat feet. This procedure involves the insertion of a trapezoidal bone graft into the calcaneus bone. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy, Pes Planus
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to 27 Nov 2018
- Phase
- Observational
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children receiving an Evans calcaneal lengthening procedure at Children's Hospital Colorado.
Who may be able to join
- Diagnosis of spastic CP or similar neuromuscular disorder
- Surgical correction of pes planovalgus, through the Evans calcaneal lengthening
- Age 4-18 years old
- Gross Motor Function Classification System (GMFCS) 1-4
- Children who are ambulatory or non-ambulatory and able to stand for plantar pressures
- Children who have or will have a first metatarsal osteotomy at the foot
Who cannot join
- Concomitant bony surgical procedures at the foot either before or concomitantly with the Evans procedure
- Gross Motor Function Classification System (GMFCS) level of 5
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
The Evans calcaneal lengthening is a common surgical correction used for children with spastic cerebral palsy (CP) and painful flat feet. This procedure involves the insertion of a trapezoidal bone graft into the calcaneus bone. Both autograft and allografting materials have been used for this procedure, but both types of grafting materials have associated limitations. Autologous grafting materials, which are harvested from the iliac crest at the time of surgery, are associated with high rates of prolonged donor site pain. There is limited bone available from the iliac crest. For this reason autologous bone grafts are not commonly used for the Evan's procedure. Cadaver allografting materials are variable in their mechanical and geometric properties. Recently, xenografting materials have been developed that have consistent mechanical properties and are available in a larger size that is formed to fit the individual patient intraoperatively. The purpose of this study is to evaluate the long term outcomes of the procedure with the different graft options. Another purpose is to compare the difference in surgical correction obtained with the cadaver allograft and the xenografting materials. This study will also observe and evaluate a wide range of outcome variables that encompass multiple levels of patient care, from clinical observation to parent and patient satisfaction, and compare these with the observed changes in the radiographic and plantar pressure parameters of the foot. This data will be evaluated pre to post surgery and for two years of follow-up time. The aim is to uncover the characteristics of collapse observed with the two different grafting materials.
Read the detailed description
Primary Outcome Measures:
- Measurement on radiographs of distance between heme clips located in calcaneous bone of the foot. Within the patient's own calcaneous bone, a heme clip will be placed on each side of the osteotomy. From radiographs, the amount of collapse will be determined by measuring the distance from one heme clip to the other. Changes in the distance between the clips indicate collapse of the graft.
- Radiographic measurements of weight bearing feet of the bovine xenograft group and iliac crest allograft group (tricortical and bicortical), pre-operatively and post-operatively.
- Lateral Radiographs: Talocalcaneal angle, Talo first metatarsal angle, Talo horizontal angle, and Calcaneal pitch
- Anterior-Posterior Radiographs: Talocalcaneal angle, Talo first metatarsal angle, and Talonavicular coverage
- Comparison of ligamentous laxity between the two grafting material groups, as measured by the Beighton measurements at patient's pre-operative orthopaedic clinical appointment.
Secondary Outcome Measures:
- Plantar pressures values of interest are of six segments: medial heel, lateral heel, medial midfoot, lateral midfoot, first metatarsal and second metatarsal. The center of pressure index, total contact area, mean pressure, peak pressure, and pressure time intervals will also be collected and assessed to determine pressure distribution of the foot.
Tertiary Outcome Measures:
- Health related quality of life assessments between the two groups, pre-operative and post-operative as measured by the Pediatric Orthopaedic Data Collection Instrument (PODCI) questionnaire.
- Conditions
- Cerebral Palsy, Pes Planus
- Keywords
- Cerebral palsy, Pes planus, Calcaneal lengthening
- Medical subject headings
- Cerebral Palsy, Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bovine Xenograft | Patients in this group received a bovine xenograft in their Evans calcaneal lengthening procedure. Up until April 2014, patients were randomized into receiving the bovine graft or allograft. However, the bovine xenograft will no longer be manufactured, so no future patients will receive the bovine xenograft during the procedure. | |
| Iliac Crest Allograft | Patients in this group received an iliac crest cadaver allograft (bicortical or tricortical) in their Evans calcaneal lengthening procedure. Up until April 2014, patients were randomized into receiving the bovine graft or allograft. However, the bovine xenograft will no longer be manufactured, so all future patients will receive the allograft during the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the amount of collapse
Measurement on radiographs of distance between heme clips located in calcaneous bone of the foot. Within the patient's own calcaneous bone, a heme clip will be placed on each side of the osteotomy. From post-operative radiographs, the amount of collapse will be determined by measuring the distance from one heme clip to the other. Post-operative changes in the distance between the clips from the first radiograph after surgery (used as a baseline, usually 6 weeks after surgery) indicate collapse of the graft.
Measured: Pre-operatively (3-12 months), 6 weeks, 6 months, and 1 and 2 years post-operatively
Secondary outcomes (1)
Change in Plantar pressures
Plantar pressures values of interest are of six segments: medial heel, lateral heel, medial midfoot, lateral midfoot, first metatarsal and second metatarsal. The center of pressure index, total contact area, mean pressure, peak pressure, and pressure time intervals will also be collected and assessed to determine pressure distribution of the foot. Change from baseline (pre-operative measurements) will be evaluated up to 2 years post-operatively. The pre-operative plantar pressures must be within a year of the surgery.
Measured: Pre-operatively (3-12 months), then 1 and 2 years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startSep 2010
- Primary completion27 Nov 2018
- Study completion27 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank M Chang, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075853
- Sponsor's protocol ID
- 10-0531
- Status last verified
- Apr 2021
- First submitted
- 26 Feb 2014
- Last updated
- 30 Apr 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of the Evans Calcaneal Lengthening Based on Bone Grafting Material
- ClinicalTrials.gov ID
- NCT02075853
- Acronym / sponsor ID
- 10-0531
- Conditions
- Cerebral Palsy, Pes Planus
- Keywords
- Cerebral palsy, Pes planus, Calcaneal lengthening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- 27 Nov 2018 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 3 Mar 2014 (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.
The Evans calcaneal lengthening is a common surgical correction used for children with spastic cerebral palsy (CP) and painful flat feet. This procedure involves the insertion of a trapezoidal bone graft into the calcaneus bone. Both autograft and allografting materials have been used for this procedure, but both types of grafting materials have associated limitations. Autologous grafting materials, which are harvested from the iliac crest at the time of surgery, are associated with high rates of prolonged donor site pain. There is limited bone available from the iliac crest. For this reason autologous bone grafts are not commonly used for the Evan's procedure. Cadaver allografting materials are variable in their mechanical and geometric properties. Recently, xenografting materials have been developed that have consistent mechanical properties and are available in a larger size that is formed to fit the individual patient intraoperatively. The purpose of this study is to evaluate the long term outcomes of the procedure with the different graft options. Another purpose is to compare the difference in surgical correction obtained with the cadaver allograft and the xenografting materials. This study will also observe and evaluate a wide range of outcome variables that encompass multiple levels of patient care, from clinical observation to parent and patient satisfaction, and compare these with the observed changes in the radiographic and plantar pressure parameters of the foot. This data will be evaluated pre to post surgery and for two years of follow-up time. The aim is to uncover the characteristics of collapse observed with the two different grafting materials.
Detailed description
Primary Outcome Measures:
- Measurement on radiographs of distance between heme clips located in calcaneous bone of the foot. Within the patient's own calcaneous bone, a heme clip will be placed on each side of the osteotomy. From radiographs, the amount of collapse will be determined by measuring the distance from one heme clip to the other. Changes in the distance between the clips indicate collapse of the graft.
- Radiographic measurements of weight bearing feet of the bovine xenograft group and iliac crest allograft group (tricortical and bicortical), pre-operatively and post-operatively.
- Lateral Radiographs: Talocalcaneal angle, Talo first metatarsal angle, Talo horizontal angle, and Calcaneal pitch
- Anterior-Posterior Radiographs: Talocalcaneal angle, Talo first metatarsal angle, and Talonavicular coverage
- Comparison of ligamentous laxity between the two grafting material groups, as measured by the Beighton measurements at patient's pre-operative orthopaedic clinical appointment.
Secondary Outcome Measures:
- Plantar pressures values of interest are of six segments: medial heel, lateral heel, medial midfoot, lateral midfoot, first metatarsal and second metatarsal. The center of pressure index, total contact area, mean pressure, peak pressure, and pressure time intervals will also be collected and assessed to determine pressure distribution of the foot.
Tertiary Outcome Measures:
- Health related quality of life assessments between the two groups, pre-operative and post-operative as measured by the Pediatric Orthopaedic Data Collection Instrument (PODCI) questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bovine Xenograft | – | –Patients in this group received a bovine xenograft in their Evans calcaneal lengthening procedure. Up until April 2014, patients were randomized into receiving the bovine graft or allograft. However, the bovine xenograft will no longer be manufactured, so no future patients will receive the bovine xenograft during the procedure. |
| Iliac Crest Allograft | – | –Patients in this group received an iliac crest cadaver allograft (bicortical or tricortical) in their Evans calcaneal lengthening procedure. Up until April 2014, patients were randomized into receiving the bovine graft or allograft. However, the bovine xenograft will no longer be manufactured, so all future patients will receive the allograft during the procedure. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children receiving an Evans calcaneal lengthening procedure at Children's Hospital Colorado.
Key inclusion criteria (6 listed)
- Diagnosis of spastic CP or similar neuromuscular disorder
- Surgical correction of pes planovalgus, through the Evans calcaneal lengthening
- Age 4-18 years old
- Gross Motor Function Classification System (GMFCS) 1-4
- Children who are ambulatory or non-ambulatory and able to stand for plantar pressures
Key exclusion criteria (2 listed)
- Concomitant bony surgical procedures at the foot either before or concomitantly with the Evans procedure
- Gross Motor Function Classification System (GMFCS) level of 5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in the amount of collapse
Time frame: Pre-operatively (3-12 months), 6 weeks, 6 months, and 1 and 2 years post-operatively
Measurement on radiographs of distance between heme clips located in calcaneous bone of the foot. Within the patient's own calcaneous bone, a heme clip will be placed on each side of the osteotomy. From post-operative radiographs, the amount of collapse will be determined by measuring the distance from one heme clip to the other. Post-operative changes in the distance between the clips from the first radiograph after surgery (used as a baseline, usually 6 weeks after surgery) indicate collapse of the graft.
1 secondary outcome
Change in Plantar pressures
Time frame: Pre-operatively (3-12 months), then 1 and 2 years post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
Frank M Chang, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Pes Planus, run by University of Colorado, Denver 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 30 Apr 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the amount of collapse (time frame: Pre-operatively (3-12 months), 6 weeks, 6 months, and 1 and 2 years post-operatively). 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 30 Apr 2021.