Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients

Flexion Contracture Clinical Trial

— KneeMD  

Official title:

A Prospective Randomized Trial to Examine the Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02638480
• Other study ID #: 811229
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: April 2019

Study information

• Verified date: February 2019
• Source: Anne Arundel Health System Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: April 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contracture
• Flexion Contracture

Intervention

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.

Locations

Country	Name	City	State
United States	Anne Arundel Medical Center	Annapolis	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Anne Arundel Health System Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AROM	Change in maximal active range of motion in	4 weeks after randomization
Secondary	AROM	Active Range of motion in degrees	2 weeks postoperatively