NCT01420887

Brief Summary

This pilot study is designed to determine if the rehabilitative benefits of continuous passive motion (CPM) will help preserve/restore the joint function and significantly improve the rate of recovery of patients after the surgical release of elbow contractures better than standard physiotherapy and static splinting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

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

First Submitted

Initial submission to the registry

July 13, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
5.3 years until next milestone

Study Start

First participant enrolled

December 18, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2020

Completed
Last Updated

July 2, 2020

Status Verified

July 1, 2020

Enrollment Period

3.4 years

First QC Date

July 13, 2011

Last Update Submit

July 1, 2020

Conditions

Elbow Injury

Keywords

CPMelbow joint surgerycontinuous passive motionRecovery after surgery to restore elbow motion

Outcome Measures

Primary Outcomes (1)

  • Recurrence of elbow contracture

    There will be an 80% statistical power to detect a difference of 2 points in the pre-surgery to post-surgery change in VAS pain between subjects in the two study arms. Similarly, there will be an 80% power to detect a difference of 16 degrees in the pre-surgery to post-surgery change in total arc of motion between the two study groups. There will be 80% power to detect a difference of at least 9 points on the pre-surgery to post-surgery difference in the DASH score.

    1 year

Secondary Outcomes (1)

  • Subsequent injury or disease of the affected elbow

    1 year

Study Arms (2)

Continuous Passive Motion

EXPERIMENTAL

Subjects randomized to CPM therapy.

Procedure: Continuous Passive Motion

Physical Therapy

ACTIVE COMPARATOR

Subjects randomized to physical therapy.

Procedure: Physical Therapy

Interventions

Continuous Passive MotionPROCEDURE

Continuous passive motion.

Continuous Passive Motion
Physical TherapyPROCEDURE

Physical therapy.

Physical Therapy

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • To be included, each patient must meet ALL of the following:
  • Lack of elbow flexion and/or extension, with or without pain.
  • The contracture must have been present for at least six months and failed to respond to non-surgical treatment.
  • Surgery to be performed will be arthroscopic capsulectomy or osteocapsular arthroplasty with removal of heterotopic ossification as necessary

You may not qualify if:

  • Contraindication to use of CPM or regional brachial plexus block, such as bleeding diathesis, use of anticoagulants or severe restriction in shoulder range of movement.
  • Progressive or recalcitrant neuropathy or neuritis, except for isolated intermittent ulnar neuritis.
  • Pre-existing factors that might limit ability to completely participate in rehabilitations such as neuromuscular or psychosocial condition.
  • Progressive or recurrent contracture due to inflammatory disease such as rheumatoid arthritis, juvenile idiopathic arthritis or chondrolysis.
  • Altered anatomy that might limit elbow motion, independent of the condition being treated, such as dysplasia, malunion, osteonecrosis, and congenital deformity.
  • A reasonable restoration of motion and function cannot be expected.
  • Inadequate postoperative regional anesthesia
  • Intra-operative or postoperative complication that could affect outcome
  • Injury or disease in the postoperative period that could affect elbow function
  • Not possible to have postoperative physical therapy appointment
  • Significant portion of the procedure performed in an open manner
  • Women that know they are pregnant or breastfeeding
  • Current or prior septic arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Elbow Injuries

Interventions

Motion Therapy, Continuous PassivePhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsMusculoskeletal Manipulations

Study Officials

  • Shawn O Driscoll, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

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
PI

Study Record Dates

First Submitted

July 13, 2011

First Posted

August 22, 2011

Study Start

December 18, 2016

Primary Completion

May 19, 2020

Study Completion

May 19, 2020

Last Updated

July 2, 2020

Record last verified: 2020-07

Locations

US(1)