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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03075319
Other study ID # MTU-EC-OT-6-049/56
Secondary ID
Status Completed
Phase N/A
First received March 4, 2017
Last updated March 9, 2017
Start date March 1, 2015
Est. completion date February 29, 2016

Study information

Verified date March 2017
Source Thammasat University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 29, 2016
Est. primary completion date February 29, 2016
Accepts healthy volunteers No
Gender All
Age group 55 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Received perioperative photograph
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.
Didn't receive perioperative photograph
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Thammasat University Krit Boontanapibul

References & Publications (12)

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. — View Citation

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. — View 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. — View Citation

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. — View 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. — View 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. — View 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. — View 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. — View Citation

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. — View 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. — View 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-A(7):1278-85. — View Citation

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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Knee society scores 6 week, 3 month and 6 month
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