Use of Perioperative Photograph as a Motivation for Increasing Range of Motion After Primary Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Received perioperative photograph
Didn't receive perioperative photograph
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- Primary OA of the knee, aged less than 80 years old, and able to understand and comply with the study procedures.
Exclusion Criteria:
- Knee range of motion less than 90 degrees
- Psychotic disorders
- History of stroke
- Inability to undergo a spinal block
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Received perioperative photograph
Didn't receive perioperative photograph
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Knee range of motion
Compare flexion and extension angle using long arm goniometer between experimental and active comparator group
Secondary Outcome Measures
Knee society scores
Full Information
NCT ID
NCT03075319
First Posted
March 4, 2017
Last Updated
March 9, 2017
Sponsor
Thammasat University
Collaborators
Boontanapibul, Krit, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT03075319
Brief Title
Use of Perioperative Photograph as a Motivation for Increasing Range of Motion After Primary Total Knee Arthroplasty
Official Title
Use of Perioperative Photograph as a Motivation for Increasing Range of Motion After Primary Total Knee Arthroplasty: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
February 29, 2016 (Actual)
Study Completion Date
February 29, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University
Collaborators
Boontanapibul, Krit, M.D.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
All participants received spinal anesthesia, multimodal local anesthetic infiltration and patient controlled analgesia (PCA) for 24 hours post surgery. The surgical techniques, postoperative medications and rehabilitation protocols were identical in both groups. 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 were given to experimental group in the day after surgery. Postoperative knee ROM were recorded at day 3, 6 week, 3 month and 6 month. The outcome assessors were blinded to treatment groups during the study period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Received perioperative photograph
Arm Type
Experimental
Arm Description
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.
Arm Title
Didn't receive perioperative photograph
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Received perioperative photograph
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Didn't receive perioperative photograph
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knee range of motion
Description
Compare flexion and extension angle using long arm goniometer between experimental and active comparator group
Time Frame
Flexion and extension angle at 6 month
Secondary Outcome Measure Information:
Title
Knee society scores
Time Frame
6 week, 3 month and 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary OA of the knee, aged less than 80 years old, and able to understand and comply with the study procedures.
Exclusion Criteria:
Knee range of motion less than 90 degrees
Psychotic disorders
History of stroke
Inability to undergo a spinal block
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piya Pinsornsak
Organizational Affiliation
Faculty of Medicine, Thammasat university
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
3612145
Citation
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.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
17823014
Citation
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.
Results Reference
result
PubMed Identifier
12068407
Citation
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.
Results Reference
result
PubMed Identifier
17823013
Citation
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.
Results Reference
result
PubMed Identifier
8245090
Citation
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.
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PubMed Identifier
12851353
Citation
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.
Results Reference
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PubMed Identifier
9802659
Citation
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Citation
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Citation
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.
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Citation
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Citation
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Results Reference
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Use of Perioperative Photograph as a Motivation for Increasing Range of Motion After Primary Total Knee Arthroplasty
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