Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients

NCT02638480 | Unknown

• 1 other identifier: 811229
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of the KneeMD subject-controlled knee rehabilitation device on the incidence of postoperative flexion contracture.

Conditions

Flexion Contracture

Outcome Measures

Primary Outcomes (1)

• AROM

  Change in maximal active range of motion in

  4 weeks after randomization

Secondary Outcomes (1)

• AROM

  2 weeks postoperatively

Study Arms (2)

Control

NO INTERVENTION

The control subjects will be treated with only the current SOC including NSAIDs and physical therapy.

Experimental

EXPERIMENTAL

The experimental subjects will be treated with current SOC and will also use a kneeMD splint 3 times a day for 20 minutes per session

Device: KneeMD

Interventions

KneeMD DEVICE

KneeMD is a subject-controlled knee rehabilita¬tion device that helps subjects who have undergone total knee replacements or other major knee surger¬ies improve range of motion and stretch in extension.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Measurable Knee Flexion Contracture, with deficit limiting Active Range of Motion (AROM) and Passive Range of Motion (PROM) by at least - 10°
• years of age and older
• Able to understand informed consent and willingness to conform to trial responsibilities

You may not qualify if:

• Previous surgical treatment of knee, including tibial osteotomy
• Botulinum Toxin Treatment within the last four months
• Mechanical joint impingement
• Neuromuscular pathologies such as epilepsy
• Treatment with quinolone, antibiotic medication
• Pregnant or nursing
• Fractures
• Osteomyelitis or any orthopedic infection
• Extensor mechanism dysfunction
• Knee joint neuropathy
• Previous Stroke or Brain Injury

Sponsors & Collaborators

• Anne Arundel Health System Research Institute: lead

Study Sites (1)

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

Related Publications (11)

• Gonzalez Della Valle A, Leali A, Haas S. Etiology and surgical interventions for stiff total knee replacements. HSS J. 2007 Sep;3(2):182-9. doi: 10.1007/s11420-007-9053-4.

  PMID: 18751792 BACKGROUND

• Pariente GM, Lombardi AV Jr, Berend KR, Mallory TH, Adams JB. Manipulation with prolonged epidural analgesia for treatment of TKA complicated by arthrofibrosis. Surg Technol Int. 2006;15:221-4.

  PMID: 17029180 BACKGROUND

• Yercan HS, Sugun TS, Bussiere C, Ait Si Selmi T, Davies A, Neyret P. Stiffness after total knee arthroplasty: prevalence, management and outcomes. Knee. 2006 Mar;13(2):111-7. doi: 10.1016/j.knee.2005.10.001. Epub 2006 Feb 20.

  PMID: 16490357 BACKGROUND

• Laubenthal KN, Smidt GL, Kettelkamp DB. A quantitative analysis of knee motion during activities of daily living. Phys Ther. 1972 Jan;52(1):34-43. doi: 10.1093/ptj/52.1.34. No abstract available.

  PMID: 5061683 BACKGROUND

• Schurman DJ, Parker JN, Ornstein D. Total condylar knee replacement. A study of factors influencing range of motion as late as two years after arthroplasty. J Bone Joint Surg Am. 1985 Sep;67(7):1006-14.

  PMID: 4030819 BACKGROUND

• Mitsuyasu H, Matsuda S, Miura H, Okazaki K, Fukagawa S, Iwamoto Y. Flexion contracture persists if the contracture is more than 15 degrees at 3 months after total knee arthroplasty. J Arthroplasty. 2011 Jun;26(4):639-43. doi: 10.1016/j.arth.2010.04.023. Epub 2010 Jun 11.

  PMID: 20541887 BACKGROUND

• Ritter MA, Lutgring JD, Davis KE, Berend ME, Pierson JL, Meneghini RM. The role of flexion contracture on outcomes in primary total knee arthroplasty. J Arthroplasty. 2007 Dec;22(8):1092-6. doi: 10.1016/j.arth.2006.11.009.

  PMID: 18078875 BACKGROUND

• Goudie ST, Deakin AH, Ahmad A, Maheshwari R, Picard F. Flexion contracture following primary total knee arthroplasty: risk factors and outcomes. Orthopedics. 2011 Dec 6;34(12):e855-9. doi: 10.3928/01477447-20111021-18.

  PMID: 22146201 BACKGROUND

• Aderinto J, Brenkel IJ, Chan P. Natural history of fixed flexion deformity following total knee replacement: a prospective five-year study. J Bone Joint Surg Br. 2005 Jul;87(7):934-6. doi: 10.1302/0301-620X.87B7.15586.

  PMID: 15972905 BACKGROUND

• Lam LO, Swift S, Shakespeare D. Fixed flexion deformity and flexion after knee arthroplasty. What happens in the first 12 months after surgery and can a poor outcome be predicted? Knee. 2003 Jun;10(2):181-5. doi: 10.1016/s0968-0160(02)00102-3.

  PMID: 12788004 BACKGROUND

• Koh IJ, Chang CB, Kang YG, Seong SC, Kim TK. Incidence, predictors, and effects of residual flexion contracture on clinical outcomes of total knee arthroplasty. J Arthroplasty. 2013 Apr;28(4):585-90. doi: 10.1016/j.arth.2012.07.014. Epub 2012 Nov 8.

  PMID: 23142447 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 23, 2015
• Study Start: November 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: February 8, 2019

Record last verified: 2019-02

Locations

US (1)