Back to resultsOpen Versus Endoscopic Surgical Management Of Posterior Calcaneal Deformity.
Primary Purpose
Bone Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
open approach
endoscopic approach
Sponsored by
About this trial
This is an interventional treatment trial for Bone Diseases
Eligibility Criteria
Inclusion Criteria:
- Symptomatic patients.
- Continued refractory pain despite use of extensive conservative management.
Exclusion Criteria:
- Asymptomatic patients
- Patients which are unfit for surgery.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
open group
endoscopic group
Arm Description
patients with posterior calcaneal deformity
patients with posterior calcaneal deformity
Outcomes
Primary Outcome Measures
the mean difference in pain scores postoperative
visual analog scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03169465
Brief Title
Open Versus Endoscopic Surgical Management Of Posterior Calcaneal Deformity.
Official Title
Open Versus Endoscopic Surgical Management Of Posterior Calcaneal (HAGLUND) Deformity. A Pilot Non Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Anticipated)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with posterior calcaneal deformity may presented by many clinical data associated with retrocalcaneal bursitis which occurs due to the deformity this clinical complaining include pain and swelling in the back of the heel.
Many treatment choices available of this deformity with low level of response to conservative treatment which includes medical treatment , physiotherapy and corticosteroids injection. surgical treatment in cases of HAGLUND deformity is the treatment of choice including either endoscopic or open surgical approach for this deformity .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
open group
Arm Type
Experimental
Arm Description
patients with posterior calcaneal deformity
Arm Title
endoscopic group
Arm Type
Active Comparator
Arm Description
patients with posterior calcaneal deformity
Intervention Type
Procedure
Intervention Name(s)
open approach
Intervention Description
open excision of the bursa and deformity then debridement of Achilles tendon
Intervention Type
Procedure
Intervention Name(s)
endoscopic approach
Intervention Description
excision of the bursa and deformity then debridement of Achilles tendon through endoscopy
Primary Outcome Measure Information:
Title
the mean difference in pain scores postoperative
Description
visual analog scale
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptomatic patients.
Continued refractory pain despite use of extensive conservative management.
Exclusion Criteria:
Asymptomatic patients
Patients which are unfit for surgery.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Open Versus Endoscopic Surgical Management Of Posterior Calcaneal Deformity.
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