Open Versus Endoscopic Surgical Management Of Posterior Calcaneal Deformity.

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03169465

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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 .

Condition or Disease	Intervention/Treatment	Phase
Bone Diseases	Procedure: open approach Procedure: endoscopic approach	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Open Versus Endoscopic Surgical Management Of Posterior Calcaneal (HAGLUND) Deformity. A Pilot Non Randomized Trial

Anticipated Study Start Date :

Jun 1, 2017

Anticipated Primary Completion Date :

May 1, 2018

Anticipated Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: open group patients with posterior calcaneal deformity	Procedure: open approach open excision of the bursa and deformity then debridement of Achilles tendon
Active Comparator: endoscopic group patients with posterior calcaneal deformity	Procedure: endoscopic approach excision of the bursa and deformity then debridement of Achilles tendon through endoscopy

Arm

Intervention/Treatment

Experimental: open group

patients with posterior calcaneal deformity

Procedure: open approach

open excision of the bursa and deformity then debridement of Achilles tendon

Active Comparator: endoscopic group

patients with posterior calcaneal deformity

Procedure: endoscopic approach

excision of the bursa and deformity then debridement of Achilles tendon through endoscopy

Outcome Measures

Primary Outcome Measures

the mean difference in pain scores postoperative [3 months]
visual analog scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Symptomatic patients.
Continued refractory pain despite use of extensive conservative management.

Exclusion Criteria:

Asymptomatic patients
Patients which are unfit for surgery.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

MAHassan, principal investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT03169465

Other Study ID Numbers:

First Posted:

May 30, 2017

Last Update Posted:

May 31, 2017

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Bone Diseases

Study Results

No Results Posted as of May 31, 2017