Late Compared to Early Physiotherapy Following Knee Dislocation

NCT ID: NCT01296750

Last Updated: 2021-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2018-09-30

Brief Summary

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A knee dislocation is an unusual and extremely serious injury and is defined as complete displacement of the tibia with respect to the femur, usually with disruption of 3 or more of the stabilizing ligaments. When the knee dislocates, there is often significant damage to the soft-tissues envelope surrounding the joint, including adjacent neurovascular structures. Not surprisingly, this injury is a profoundly debilitating, life-altering event, with the potential to necessitate career change in athletes and laborers alike. Current evidence indicates that operative management for these injuries is more effective at returning patients to pre-morbid range of motion (ROM) and activity than conservative management. Post operative rehabilitation programs for these patients must balance the need for stability of their surgical repair and knee ROM and functionality. Experimental data suggests that post-operative immobilization offers greater protection of the surgical reconstruction, whereas immediate, aggressive physiotherapy may be more effective at preventing arthrofibrosis stiffness. The investigators are proposing a randomized clinical trial comparing early physiotherapy (day one post op) versus immobilization for three weeks then initiation of physiotherapy. The physiotherapy progams will be identicalbe in all aspects except for progam initiation.

Detailed Description

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Conditions

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Traumatic Knee Dislocation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early Physiotherapy

Physiotherapy to begin within 1 day post op.

Group Type ACTIVE_COMPARATOR

Early Physiotherapy start

Intervention Type OTHER

Physiotherapy starting at one day post op

Late Physiotherapy

Physiotherapy to start 6 weeks post op

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Early Physiotherapy start

Physiotherapy starting at one day post op

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Ambulation without aids in pre-morbid condition
* Multi-ligament knee injury with or without associated peri-articular fracture
* Operative management within three weeks of the injury

Exclusion Criteria

* Poly-trauma with life-threatening injuries preventing rehabilitation
* Patients unable to comply with intensive rehabilitation
* Patients unable or unlikely to maintain follow-up
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Hoit G, Rubacha M, Chahal J, Khan R, Ravi B, Whelan DB. Is There a Disadvantage to Early Physical Therapy After Multiligament Surgery for Knee Dislocation? A Pilot Randomized Clinical Trial. Clin Orthop Relat Res. 2021 Aug 1;479(8):1725-1736. doi: 10.1097/CORR.0000000000001729.

Reference Type DERIVED
PMID: 33729214 (View on PubMed)

Other Identifiers

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SMH Co_LEAP

Identifier Type: -

Identifier Source: org_study_id

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