NCT03169465

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

May 25, 2017

Last Update Submit

May 29, 2017

Conditions

Bone Diseases

Outcome Measures

Primary Outcomes (1)

  • the mean difference in pain scores postoperative

    visual analog scale

    3 months

Study Arms (2)

open group

EXPERIMENTAL

patients with posterior calcaneal deformity

Procedure: open approach

endoscopic group

ACTIVE COMPARATOR

patients with posterior calcaneal deformity

Procedure: endoscopic approach

Interventions

open approachPROCEDURE

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

open group
endoscopic approachPROCEDURE

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

endoscopic group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Asymptomatic patients
  • Patients which are unfit for surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bone Diseases

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 25, 2017

First Posted

May 30, 2017

Study Start

June 1, 2017

Primary Completion

May 1, 2018

Study Completion

August 1, 2018

Last Updated

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share