Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients (KneeMD)

• ClinicalTrials.gov Identifier: NCT02638480
• Recruitment Status: Active, not recruiting
• First Posted: December 23, 2015
• Last Update Posted: February 8, 2019
• Sponsor: Anne Arundel Health System Research Institute
• Information provided by (Responsible Party): Anne Arundel Health System Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Flexion Contracture	Device: KneeMD	Not Applicable

Detailed Description:

Postoperative flexion contracture (FC), defined as >10°, is the most common disabling early complication of primary total knee replacement (TKR) surgery, affecting up to 6% of all subjects. A knee flexion of 65° is required to walk, 70° is needed to lift an object from the floor, 85° to climb stairs, 95° for optimal sitting and standing, and 105° to tie shoelaces. With growing subject and physician expectations for function and range of motion (ROM) after surgery, FC complications have become an early measure of success in TKR surgery.

The purpose of this study is to evaluate the effect of the KneeMD subject-controlled knee rehabilitation device on the incidence of postoperative FC. The primary endpoints are the preoperative change in active range of motion (AROM) and the incidence of postoperative FC at 2 weeks. Secondary endpoints include the change in AROM in subjects with postoperative FC.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Trial to Examine the Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients
• Study Start Date: November 2015
• Estimated Primary Completion Date: March 2019
• Estimated Study Completion Date: April 2019

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. AROM [ Time Frame: 4 weeks after randomization ]
   Change in maximal active range of motion in

Secondary Outcome Measures :

1. AROM [ Time Frame: 2 weeks postoperatively ]
   Active Range of motion in degrees

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Measurable Knee Flexion Contracture, with deficit limiting Active Range of Motion (AROM) and Passive Range of Motion (PROM) by at least - 10°
2. 18 years of age and older
3. Able to understand informed consent and willingness to conform to trial responsibilities

Exclusion Criteria:

1. Previous surgical treatment of knee, including tibial osteotomy
2. Botulinum Toxin Treatment within the last four months
3. Mechanical joint impingement
4. Neuromuscular pathologies such as epilepsy
5. Treatment with quinolone, antibiotic medication
6. Pregnant or nursing
7. Fractures
8. Osteomyelitis or any orthopedic infection
9. Extensor mechanism dysfunction
10. Knee joint neuropathy
11. Previous Stroke or Brain Injury

Contacts and Locations

Locations

United States, Maryland

Anne Arundel Medical Center

Annapolis, Maryland, United States, 21401

Sponsors and Collaborators

Anne Arundel Health System Research Institute

More Information

Publications:

González 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.

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.

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. Epub 2006 Feb 20.

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.

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.

Mitsuyasu H, Matsuda S, Miura H, Okazaki K, Fukagawa S, Iwamoto Y. Flexion contracture persists if the contracture is more than 15° 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.

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.

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.

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.

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.

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.

• Responsible Party: Anne Arundel Health System Research Institute
• ClinicalTrials.gov Identifier: NCT02638480
• Other Study ID Numbers: 811229
• First Posted: December 23, 2015
• Last Update Posted: February 8, 2019
• Last Verified: February 2019

Additional relevant MeSH terms:

Contracture; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases