- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02075853
Outcomes of the Evans Calcaneal Lengthening Based on Bone Grafting Material
Study Overview
Status
Conditions
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:
1. 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:
1. 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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Children's Hospital Colorado
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Concomitant bony surgical procedures at the foot either before or concomitantly with the Evans procedure
- Gross Motor Function Classification System (GMFCS) level of 5
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Pre-operatively (3-12 months), 6 weeks, 6 months, and 1 and 2 years post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Plantar pressures
Time Frame: Pre-operatively (3-12 months), then 1 and 2 years post-operatively
|
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.
|
Pre-operatively (3-12 months), then 1 and 2 years post-operatively
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Health related quality of life
Time Frame: Pre-operativey (3-12 months), then at 6 months, 1 and 2 years post-operatively
|
Health related quality of life assessments between the two groups, preoperative and post-operative as measured by the Pediatric Orthopaedic Data Collection Instrument (PODCI) questionnaire.
Pre-operative assessments must be within a year before surgery, and post-operative assessments will be conducted up to 2 years post-operatively to compare the changes from baseline (from pre-operative assessment).
|
Pre-operativey (3-12 months), then at 6 months, 1 and 2 years post-operatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Frank M Chang, MD, Children's Hospital Colorado
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Congenital Abnormalities
- Brain Damage, Chronic
- Musculoskeletal Diseases
- Musculoskeletal Abnormalities
- Limb Deformities, Congenital
- Foot Deformities
- Foot Deformities, Acquired
- Foot Deformities, Congenital
- Lower Extremity Deformities, Congenital
- Talipes
- Cerebral Palsy
- Flatfoot
Other Study ID Numbers
- 10-0531
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
Northwestern UniversityActive, not recruitingCerebral Palsy | Diplegic Cerebral Palsy | Bilateral Cerebral PalsyUnited States
-
Centre Médico-Chirurgical de Réadaptation des Massues...RecruitingCerebral Palsy, Dyskinetic | Cerebral Palsy, Spastic | Infantile Hemiplegic Cerebral PalsyFrance
-
St Mary's University CollegeUniversity of GloucestershireUnknownCerebral Palsy | Cerebral Palsy Ataxic | Cerebral Palsy, MixedUnited Kingdom
-
Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium
-
University of California, San FranciscoNational Institutes of Health (NIH)RecruitingDystonic Cerebral Palsy | Dyskinetic Cerebral PalsyUnited States
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
-
East Carolina UniversityRecruitingHemiplegic Cerebral Palsy | Unilateral Cerebral Palsy | Remote Ischemic ConditioningUnited States
-
October 6 UniversityCompletedSpastic Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyEgypt
-
Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey