NCT03075319

Brief Summary

Total knee arthroplasty (TKA) is recognized as a successful procedure for treating osteoarthritis (OA) of the knee. One important factor that make the successful surgery is the degree of knee flexion. Providing more range of motion after TKA impact on the convenience of daily of life such as climbing stairs, sitting on the floor particularly in Asian cultures which require a lot of ground activities. Data are limited on the added benefits of perioperative photograph as motivation for increasing range of motion after TKA. Half of participants received perioperative photograph as motivation, while the other half did not after total knee arthroplasty.

Trial Health

100
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 Mar 2015

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 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 4, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

March 4, 2017

Last Update Submit

March 9, 2017

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

  • Knee range of motion

    Compare flexion and extension angle using long arm goniometer between experimental and active comparator group

    Flexion and extension angle at 6 month

Secondary Outcomes (1)

  • Knee society scores

    6 week, 3 month and 6 month

Study Arms (2)

Received perioperative photograph

EXPERIMENTAL

Perioperative knee range of motion (ROM) were measured with long arm goniometer immediately after close the wound. Perioperative knee photographs in full flexion and extension positions were taken and gave to experimental group in the day after surgery.

Procedure: Received perioperative photograph

Didn't receive perioperative photograph

ACTIVE COMPARATOR

Perioperative knee range of motion (ROM) were measured with long arm goniometer immediately after close the wound. Perioperative knee photographs in full flexion and extension positions were taken but participants in this group didn't receive perioperative photographs.

Procedure: Didn't receive perioperative photograph

Interventions

Received perioperative photographPROCEDURE

All participants in experimental group were adviced to see periopertive knee photograph before rehabilitation everyday. Postoperative knee ROM were recorded at day 3, 6 week, 3 month and 6 month. Flexion and extension angle were measured with long arm goniometer. The outcome assessors were blinded to treatment groups.

Received perioperative photograph
Didn't receive perioperative photographPROCEDURE

All participants in active comparator group didn't receive perioperative knee photograph. Postoperative knee ROM were recorded at day 3, 6 week, 3 month and 6 month. Flexion and extension angle were measured with long arm goniometer. The outcome assessors were blinded to treatment groups.

Didn't receive perioperative photograph

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary OA of the knee, aged less than 80 years old, and able to understand and comply with the study procedures.

You may not qualify if:

  • Knee range of motion less than 90 degrees
  • Psychotic disorders
  • History of stroke
  • Inability to undergo a spinal block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Ritter MA, Campbell ED. Effect of range of motion on the success of a total knee arthroplasty. J Arthroplasty. 1987;2(2):95-7. doi: 10.1016/s0883-5403(87)80015-3.

    PMID: 3612145RESULT

  • Miner AL, Lingard EA, Wright EA, Sledge CB, Katz JN; Kinemax Outcomes Group. Knee range of motion after total knee arthroplasty: how important is this as an outcome measure? J Arthroplasty. 2003 Apr;18(3):286-94. doi: 10.1054/arth.2003.50046.

    PMID: 12728419RESULT

  • Meneghini RM, Pierson JL, Bagsby D, Ziemba-Davis M, Berend ME, Ritter MA. Is there a functional benefit to obtaining high flexion after total knee arthroplasty? J Arthroplasty. 2007 Sep;22(6 Suppl 2):43-6. doi: 10.1016/j.arth.2007.03.011. Epub 2007 Jul 26.

    PMID: 17823014RESULT

  • Kurosaka M, Yoshiya S, Mizuno K, Yamamoto T. Maximizing flexion after total knee arthroplasty: the need and the pitfalls. J Arthroplasty. 2002 Jun;17(4 Suppl 1):59-62. doi: 10.1054/arth.2002.32688.

    PMID: 12068407RESULT

  • Fisher DA, Dierckman B, Watts MR, Davis K. Looks good but feels bad: factors that contribute to poor results after total knee arthroplasty. J Arthroplasty. 2007 Sep;22(6 Suppl 2):39-42. doi: 10.1016/j.arth.2007.04.011. Epub 2007 Jul 26.

    PMID: 17823013RESULT

  • Harvey IA, Barry K, Kirby SP, Johnson R, Elloy MA. Factors affecting the range of movement of total knee arthroplasty. J Bone Joint Surg Br. 1993 Nov;75(6):950-5. doi: 10.1302/0301-620X.75B6.8245090.

    PMID: 8245090RESULT

  • Ritter MA, Harty LD, Davis KE, Meding JB, Berend ME. Predicting range of motion after total knee arthroplasty. Clustering, log-linear regression, and regression tree analysis. J Bone Joint Surg Am. 2003 Jul;85(7):1278-85. doi: 10.2106/00004623-200307000-00014.

    PMID: 12851353RESULT

  • Dennis DA, Komistek RD, Stiehl JB, Walker SA, Dennis KN. Range of motion after total knee arthroplasty: the effect of implant design and weight-bearing conditions. J Arthroplasty. 1998 Oct;13(7):748-52. doi: 10.1016/s0883-5403(98)90025-0.

    PMID: 9802659RESULT

  • Sharma L, Sinacore J, Daugherty C, Kuesis DT, Stulberg SD, Lewis M, Baumann G, Chang RW. Prognostic factors for functional outcome of total knee replacement: a prospective study. J Gerontol A Biol Sci Med Sci. 1996 Jul;51(4):M152-7. doi: 10.1093/gerona/51a.4.m152.

    PMID: 8680997RESULT

  • Bonnin M, Laurent JR, Parratte S, Zadegan F, Badet R, Bissery A. Can patients really do sport after TKA? Knee Surg Sports Traumatol Arthrosc. 2010 Jul;18(7):853-62. doi: 10.1007/s00167-009-1009-4. Epub 2009 Dec 24.

    PMID: 20033676RESULT

  • Naylor JM, Ko V, Adie S, Gaskin C, Walker R, Harris IA, Mittal R. Validity and reliability of using photography for measuring knee range of motion: a methodological study. BMC Musculoskelet Disord. 2011 Apr 18;12:77. doi: 10.1186/1471-2474-12-77.

    PMID: 21496347RESULT

  • Gogia PP, Braatz JH, Rose SJ, Norton BJ. Reliability and validity of goniometric measurements at the knee. Phys Ther. 1987 Feb;67(2):192-5. doi: 10.1093/ptj/67.2.192.

    PMID: 3809242RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Piya Pinsornsak

    Faculty of Medicine, Thammasat university

    PRINCIPAL INVESTIGATOR

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

March 4, 2017

First Posted

March 9, 2017

Study Start

March 1, 2015

Primary Completion

February 29, 2016

Study Completion

February 29, 2016

Last Updated

March 13, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share