NCT03015415

Brief Summary

This study compares patients with post traumatic elbow stiffness and evaluate the range of motion improvement with two types of treatment: surgical release versus non-surgical rehabilitation protocol with orthoses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 3, 2013

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2018

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2018

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

5.6 years

First QC Date

January 5, 2017

Last Update Submit

May 16, 2020

Conditions

Elbow Joint ContractureElbow Flexion ContracturesElbow InjuryElbow Osteoarthritis

Keywords

elbowposttraumatic stiffnesselbow contracturesstiff elbowdynamic orthosesDynamic splintRehabilitationSplintEffectiveness of bracing

Outcome Measures

Primary Outcomes (1)

  • Elbow range of motion improvement in degrees

    The gain will be measured with a goniometer centered on the axis of rotation of the elbow by a external examiner.

    6 months

Study Arms (2)

surgical

EXPERIMENTAL

Patients undergoing surgical elbow arthrolysis. Elbow Open Arthrolyses

Procedure: Elbow Open Arthrolyses

non-surgical

EXPERIMENTAL

Patients submitted to a non-surgical rehabilitation protocol using splints Non-surgical intervention

Procedure: Non-surgical intervention

Interventions

Elbow Open ArthrolysesPROCEDURE

Elbow arthrolysis by posterior access

Also known as: surgical
surgical
Non-surgical interventionPROCEDURE

Rehabilitation with splinting protocols

non-surgical

Eligibility Criteria

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

You may qualify if:

  • Previous history of trauma that evolved with joint stiffness at the elbow
  • Range of movement of the elbow less than 100º or extension deficit greater than 30º or flexion less than 130º
  • More than six months from the initial trauma;
  • Skeletal maturity;
  • Have had previous physical therapy without the use of orthotics or continuous passive motion for at least 4 months;
  • Absence of the following findings:
  • Joint block, with range of motion equal to 0º;
  • Neurological limb injury;
  • Mental illness or inability to understand preoperative questionnaires;
  • Active infection;
  • Anterior infection at the elbow;
  • Systemic autoimmune diseases. (Eg, systemic lupus erythematosus, rheumatoid arthritis, joint psoriasis, etc.).
  • Absence of the following radiographic changes:
  • Intra-articular synthesis material;
  • Presence of vicious consolidation of the distal articular surface of the humerus and proximal ulna;
  • +4 more criteria

You may not qualify if:

  • Non-collaboration with rehabilitation program and postoperative follow-up;
  • Need to use external fixator after surgical release due to joint instability;
  • Death from non-intervention causes or loss of follow-up before the first functional evaluation (3 months).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Ortopedia e Traumatologia

São Paulo, 05403-010, Brazil

Location

MeSH Terms

Conditions

Elbow Injuries

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and Injuries

Study Officials

  • Rames M Junior, Professor

    University of Sao Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 10, 2017

Study Start

March 3, 2013

Primary Completion

September 20, 2018

Study Completion

October 12, 2018

Last Updated

May 19, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)