Static Progressive Splinting in the Management of Knee Stiffness Following Total Knee Arthroplasty

NCT04837872 | Completed

• 1 other identifier: 17-0241
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the feasibility and initial efficacy of static progressive splinting for individuals presenting with knee stiffness following total knee arthroplasty (TKA). Data from this trial will be utilized in a NIH grant application for a larger randomized controlled trial directly comparing static progressive splinting to manipulation under anesthesia (MUA) which is the current standard of care for knee stiffness after TKA.

Conditions

Arthroplasty, Replacement, Knee

Keywords

static progressive splinting; manual therapy; physical therapy; rehabilitation; arthrofibrosis

Outcome Measures

Primary Outcomes (1)

• Range of Motion

  Passive knee flexion and extension measured with goniometry

  4 weeks

Secondary Outcomes (3)

• Adherence to Splint Use

  4 weeks

• Satisfaction with Splint

  4 weeks

• Safety of splint use: adverse events

  4 weeks

Study Arms (1)

Multimodal Physical Therapy (MPT)

EXPERIMENTAL

The multimodal physical therapy (MPT) program consisted of manual therapy, therapeutic exercise, and utilization of a static progressive splint (Joint Active Systems SPS Knee, Effingham, IL). Although the primary focus of this study was on improving knee flexion ROM, two protocols were developed: one to improve flexion deficits and one to improve extension deficits. Participants in the MPT group received physical therapy 2x per week for 4 weeks. They were instructed to use the static progressive splint(s) 3x per day for 30 minute sessions (90 minutes total per day) for each splint (e.g., 90 minutes for flexion splint, 90 minutes for extension splint).

Other: Multimodal Physical Therapy (MPT)

Interventions

Multimodal Physical Therapy (MPT) OTHER

Individualized physical therapy and static progressive splint (flexion with or without extension splint).

Multimodal Physical Therapy (MPT)

Eligibility Criteria

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

You may qualify if:

• Undergone a unilateral primary Total Knee Arthroplasty (TKA) for end-stage osteoarthritis
• Knee stiffness in the first 6 weeks post-operative defined as knee flexion \< 100 degrees

You may not qualify if:

• Preoperative knee range of motion less than 15-110 degrees
• Intraoperative (closed) range of motion \< 0-120 degrees
• Radiographic signs of heterotopic ossification
• Misaligned components or component-related failures of knee prosthesis that could be responsible for difficulties with motion
• Signs and symptoms consistent with joint infection
• Signs and symptoms consistent with complex regional pain syndrome

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Panorama Orthopedics & Spine Center: collaborator

Study Sites (1)

Panorama Orthopedics & Spine Center

Golden, Colorado, 80401, United States

Location

Related Publications (8)

• 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

• Schroer WC, Berend KR, Lombardi AV, Barnes CL, Bolognesi MP, Berend ME, Ritter MA, Nunley RM. Why are total knees failing today? Etiology of total knee revision in 2010 and 2011. J Arthroplasty. 2013 Sep;28(8 Suppl):116-9. doi: 10.1016/j.arth.2013.04.056. Epub 2013 Aug 15.

  PMID: 23954423 BACKGROUND

• Schairer WW, Vail TP, Bozic KJ. What are the rates and causes of hospital readmission after total knee arthroplasty? Clin Orthop Relat Res. 2014 Jan;472(1):181-7. doi: 10.1007/s11999-013-3030-7.

  PMID: 23645339 BACKGROUND

• Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.

  PMID: 17403800 BACKGROUND

• Bonutti PM, Marulanda GA, McGrath MS, Mont MA, Zywiel MG. Static progressive stretch improves range of motion in arthrofibrosis following total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2010 Feb;18(2):194-9. doi: 10.1007/s00167-009-0947-1. Epub 2009 Oct 14.

  PMID: 19826784 BACKGROUND

• Manrique J, Gomez MM, Parvizi J. Stiffness after total knee arthroplasty. J Knee Surg. 2015 Apr;28(2):119-26. doi: 10.1055/s-0034-1396079. Epub 2014 Dec 16.

  PMID: 25513992 BACKGROUND

• Witvrouw E, Bellemans J, Victor J. Manipulation under anaesthesia versus low stretch device in poor range of motion after TKA. Knee Surg Sports Traumatol Arthrosc. 2013 Dec;21(12):2751-8. doi: 10.1007/s00167-012-2152-x. Epub 2012 Aug 3.

  PMID: 22864680 BACKGROUND

• Rauzi MR, Foran JRH, Bade MJ. Multimodal conservative management of arthrofibrosis after total knee arthroplasty compared to manipulation under anesthesia: a feasibility study with retrospective cohort comparison. Pilot Feasibility Stud. 2022 Mar 25;8(1):71. doi: 10.1186/s40814-022-01026-y.

  PMID: 35337388 DERIVED

Related Links

• Most Frequent Operating Room Procedures Performed in U.S. Hospitals, 2003-2012

Study Design

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

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: May 25, 2017
• Primary Completion: February 27, 2018
• Study Completion: February 12, 2019
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)