NCT04686071

Brief Summary

Background: Early rehabilitation following knee arthroplasty is an integral part of medical management which reduces the time of patient's stay at hospital and eliminates the risk of post-operative complications. The absence of consensus on the most efficient post-operative rehabilitation strategy and shortage of practices based on evidence lead to seek new therapeutic solutions. Therefore the goal of this study is to evaluate the efficiency of the PNF method in assessing functional performance in early stage patients following knee arthroplasty Material and methods: The study was conducted among 96 patients (66,34 years ±7,29) who were qualified to total knee arthroplasty. The patients were randomly divided into two groups. In the control group standard rehabilitation protocol was implemented while post-operative treatment in the study group based on PNF method. All the patients were tested on the day of admission to the hospital and after completing a 10-day rehabilitation program. Structural and functional parameters of the operated knee (muscle strength, range of motion, circuit measurements) as well as functional abilities (Staffelstein Score, Lequesne Index) were evaluated. Key words: gonarthrosis, knee replacement, osteoarthritis, PNF method

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

January 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
Last Updated

December 28, 2020

Status Verified

December 1, 2020

Enrollment Period

2.9 years

First QC Date

December 11, 2020

Last Update Submit

December 22, 2020

Conditions

Keywords

gonarthrosis, knee replacement, osteoarthritis, PNF method

Outcome Measures

Primary Outcomes (7)

  • muscle strength test

    (6-point Lovett scale)

    baseline

  • muscle strength test

    (6-point Lovett scale)

    at 10 days

  • range of motiondigital inclinometer

    baseline,

  • range of motiondigital inclinometer

    at 10 days

  • circuits measurement (centimeter)

    Circuits were measured on the level of the knee joint articular space, 10 cm (Thigh I) and 20 cm (Thigh II) above the articular space as well as on the level of lower leg (the widest point).

    baseline, at 10 days

  • Staffelstein Score

    subjective evaluation to assess functional abilities

    baseline,

  • Lequesne Index

    subjective evaluationto assess functional abilities

    at 10 days

Study Arms (2)

PNF method

EXPERIMENTAL
Other: PNF method

standard rehabilitation

OTHER
Other: Standard rehabilitation

Interventions

Treatment in the study group was conducted with PNF method with a use of indirect training based on irradiation phenomenon. The program included: proprioceptive stimulation of the operated limb, improving trunk stabilization and active control, active foot training, muscle strength facilitation of lower limbs in closed kinematic chain with considering periarticular stabilization within the operated knee joint as well as exercises improving mobility of the operated knee, verticalization and locomotion with emphasis on the stance phase.

PNF method

In the control group standard rehabilitation protocol was used in patients following TKA, which is mainly based on activities in open chains (passive exercises with continuous passive motion (CMP) device, active exercises, isometric, active resistance, patella mobilization, deep tissue massage, verticalization and gait relearning).

standard rehabilitation

Eligibility Criteria

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

You may qualify if:

  • the total knee arthroplasty due to pain caused by advanced knee osteoarthritis.

You may not qualify if:

  • stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Krakowskie Centrum Rehabilitacji i Ortopedii

Krakow, Małopolska, 30-224, Poland

Location

Tomasz Maicki

Krakow, Poland

Location

Related Publications (8)

  • Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.

    PMID: 24553908BACKGROUND
  • Conaghan PG, Kloppenburg M, Schett G, Bijlsma JW; EULAR osteoarthritis ad hoc committee. Osteoarthritis research priorities: a report from a EULAR ad hoc expert committee. Ann Rheum Dis. 2014 Aug;73(8):1442-5. doi: 10.1136/annrheumdis-2013-204660. Epub 2014 Mar 13.

    PMID: 24625626BACKGROUND
  • Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001.

    PMID: 20699159BACKGROUND
  • Chojnacki M, Kwapisz A, Synder M, Szemraj J. [Osteoarthritis: etiology, risk factors, molecular mechanisms]. Postepy Hig Med Dosw (Online). 2014 Jan 2;68:640-52. doi: 10.5604/17322693.1103551. Polish.

    PMID: 24864114BACKGROUND
  • Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M; Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1145-55. doi: 10.1136/ard.2003.011742.

    PMID: 14644851BACKGROUND
  • National Clinical Guideline Centre [editorial]. Osteoarhritis: care and management in adults. NICE 2014;177: 1-36

    BACKGROUND
  • Davila Castrodad IM, Recai TM, Abraham MM, Etcheson JI, Mohamed NS, Edalatpour A, Delanois RE. Rehabilitation protocols following total knee arthroplasty: a review of study designs and outcome measures. Ann Transl Med. 2019 Oct;7(Suppl 7):S255. doi: 10.21037/atm.2019.08.15.

    PMID: 31728379BACKGROUND
  • Papalia R, Campi S, Vorini F, Zampogna B, Vasta S, Papalia G, Fossati C, Torre G, Denaro V. The Role of Physical Activity and Rehabilitation Following Hip and Knee Arthroplasty in the Elderly. J Clin Med. 2020 May 9;9(5):1401. doi: 10.3390/jcm9051401.

    PMID: 32397459BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patients were randomly divided into two groups which differed in the type of a 10-day treatment model used after the operation.Specifying the group was done by drawing a sealed, opaque envelope: an envelope with an even number ment PNF treatment, while an odd number ment traditional therapy.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal

Study Record Dates

First Submitted

December 11, 2020

First Posted

December 28, 2020

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 28, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
available
Access Criteria
on email request: tomasz.maicki@uj.edu.pl

Locations