NCT02409719

Brief Summary

The investigators include patients attending the outpatient clinic in the area of Orthopedics and Traumatology of the investigators hospital with a diagnosis of knee osteoarthritis, which treatment requires surgery. Patients will be divided into two groups. In both groups, they will be given verbal, clear and detailed information on the approach to follow, the exercises given in brochures, and in the study group a schedule will be given in order to record rehabilitation exercises in patients after total knee replacement (TKA). Both groups will be assessed before and after surgery, together with outpatient follow-up by, WOMAC, Visual Analogue Scale and OKS (Oxford Knee Score).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

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

July 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

December 19, 2019

Completed
Last Updated

December 19, 2019

Status Verified

December 1, 2019

Enrollment Period

4.5 years

First QC Date

March 30, 2015

Results QC Date

October 21, 2019

Last Update Submit

December 2, 2019

Conditions

OsteoarthritisRehabilitation

Keywords

Arthritis, DegenerativeRecovery of function

Outcome Measures

Primary Outcomes (1)

  • Total WOMAC Score

    The total score is provided for Western Ontario and McMaster Universities Arthritis Index (WOMAC). It is a widely score used in the evaluation of Hip and Knee Osteoarthritis. Consists of a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain (5 items), stiffness (2 items), and physical functioning (17 items) of the joints. * Scale Range: 5 items of pain (score range 0-20), 2 items for stiffness (score range 0-8), and 17 items for functional limitation (score range 0-68). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Total WOMAC score range 0-96. * For each subscale higher values represent worse outcomes. * Subscales are summed for a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. WOMAC Index was developed in 1982 at Western Ontario and McMaster Universities.

    up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)

Secondary Outcomes (1)

  • Visual Analog Scale (Measure of Pain Intensity)

    up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)

Other Outcomes (1)

  • Oxford Knee Score (OKS)

    up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)

Study Arms (2)

Control - Verbal information and Booklet

ACTIVE COMPARATOR

Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given.

Other: Verbal Information and Booklet

Study - Verbal information, Booklet & Schedule.

EXPERIMENTAL

Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the exact day in which the exercise was performed

Other: ScheduleOther: Verbal Information and Booklet

Interventions

ScheduleOTHER

Illustrative daily planner to point the day that the exercise was performed

Also known as: Planner
Study - Verbal information, Booklet & Schedule.
Verbal Information and BookletOTHER

Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the exact day in which the exercise was performed

Also known as: Verbal and Booklet Physical Rehabilitation information
Control - Verbal information and BookletStudy - Verbal information, Booklet & Schedule.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 90 years
  • Patients with Knee osteoarthritis (OA) grade 4 ( Kellgren-Lawrence based on radiographic findings)
  • Total Knee Arthroplasty (TKA) for primary OA
  • Rapid rehabilitation desire

You may not qualify if:

  • Age \<18 and \> 90 years
  • Patients with Knee osteoarthritis grade 1-2 ( Kellgren-Lawrence based on radiographic findings)
  • Patients with asociated Rheumatic syndromes
  • Patients with anticoagulant therapy
  • Patients with hepatic problems, Diabetes Mellitus, Coagulopathy, hearth conditions, immunodepressed, or infections
  • Drugs abuse history
  • Physiatric disease
  • Pregnant patients
  • Patients with hemoglobin values \< 11g/dl , platelets \< 150,000/ μL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Medicina UANL

Monterrey, Nuevo León, 66235, Mexico

Location

Related Publications (11)

  • Minns Lowe CJ, Barker KL, Dewey M, Sackley CM. Effectiveness of physiotherapy exercise after knee arthroplasty for osteoarthritis: systematic review and meta-analysis of randomised controlled trials. BMJ. 2007 Oct 20;335(7624):812. doi: 10.1136/bmj.39311.460093.BE. Epub 2007 Sep 20.

    PMID: 17884861BACKGROUND

  • Meier W, Mizner RL, Marcus RL, Dibble LE, Peters C, Lastayo PC. Total knee arthroplasty: muscle impairments, functional limitations, and recommended rehabilitation approaches. J Orthop Sports Phys Ther. 2008 May;38(5):246-56. doi: 10.2519/jospt.2008.2715. Epub 2007 Dec 14.

    PMID: 18448878BACKGROUND

  • Labraca NS, Castro-Sanchez AM, Mataran-Penarrocha GA, Arroyo-Morales M, Sanchez-Joya Mdel M, Moreno-Lorenzo C. Benefits of starting rehabilitation within 24 hours of primary total knee arthroplasty: randomized clinical trial. Clin Rehabil. 2011 Jun;25(6):557-66. doi: 10.1177/0269215510393759. Epub 2011 Mar 7.

    PMID: 21382863BACKGROUND

  • Kauppila AM, Sintonen H, Aronen P, Ohtonen P, Kyllonen E, Arokoski JP. Economic evaluation of multidisciplinary rehabilitation after primary total knee arthroplasty based on a randomized controlled trial. Arthritis Care Res (Hoboken). 2011 Mar;63(3):335-41. doi: 10.1002/acr.20398. Epub 2010 Nov 15.

    PMID: 21080347BACKGROUND

  • DiSotto-Monastero M, Chen X, Fisch S, Donaghy S, Gomez M. Efficacy of 7 days per week inpatient admissions and rehabilitation therapy. Arch Phys Med Rehabil. 2012 Dec;93(12):2165-9. doi: 10.1016/j.apmr.2012.07.003. Epub 2012 Jul 20.

    PMID: 22819810BACKGROUND

  • Ribinik P, Le Moine F, de Korvin G, Coudeyre E, Genty M, Rannou F, Yelnik A, Calmels P. Physical and rehabilitation medicine (PRM) care pathways: "patients after total knee arthroplasty". Ann Phys Rehabil Med. 2012 Nov;55(8):533-9. doi: 10.1016/j.rehab.2012.02.001. Epub 2012 Mar 3.

    PMID: 22455993BACKGROUND

  • Bandholm T, Kehlet H. Physiotherapy exercise after fast-track total hip and knee arthroplasty: time for reconsideration? Arch Phys Med Rehabil. 2012 Jul;93(7):1292-4. doi: 10.1016/j.apmr.2012.02.014. Epub 2012 Feb 27.

    PMID: 22494947BACKGROUND

  • Nakai T, Tamaki M, Nakamura T, Nakai T, Onishi A, Hashimoto K. Controlling pain after total knee arthroplasty using a multimodal protocol with local periarticular injections. J Orthop. 2013 Mar 17;10(2):92-4. doi: 10.1016/j.jor.2013.02.001. eCollection 2013.

    PMID: 24403757BACKGROUND

  • Madsen M, Larsen K, Madsen IK, Soe H, Hansen TB. Late group-based rehabilitation has no advantages compared with supervised home-exercises after total knee arthroplasty. Dan Med J. 2013 Apr;60(4):A4607.

    PMID: 23651717BACKGROUND

  • Ibrahim MS, Khan MA, Nizam I, Haddad FS. Peri-operative interventions producing better functional outcomes and enhanced recovery following total hip and knee arthroplasty: an evidence-based review. BMC Med. 2013 Feb 13;11:37. doi: 10.1186/1741-7015-11-37.

    PMID: 23406499BACKGROUND

  • Lamplot JD, Wagner ER, Manning DW. Multimodal pain management in total knee arthroplasty: a prospective randomized controlled trial. J Arthroplasty. 2014 Feb;29(2):329-34. doi: 10.1016/j.arth.2013.06.005. Epub 2013 Jul 11.

    PMID: 23850410BACKGROUND

Related Links

MeSH Terms

Conditions

Osteoarthritis

Interventions

Appointments and Schedules

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Organization and AdministrationHealth Services Administration

Results Point of Contact

Title
FELIX VILCHEZ CAVAZOS
Organization
Universidad Autonoma de Nuevo Leon
vilchez.doctor@gmail.com
8183476698

Study Officials

  • Felix Vilchez, MD-PhD

    Universidad Autonoma de Nuevo Leon

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

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
MD-PhD

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 7, 2015

Study Start

July 1, 2014

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

December 19, 2019

Results First Posted

December 19, 2019

Record last verified: 2019-12

Locations

ME(1)