Joint Movement to Increase Range of Motion in Knee Joint After Primary Total Knee Arthroplasty

NCT06188091 | Completed DMC

• 1 other identifier: 22020545
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trail is to investigate if specific active exercises, with a certain daily frequency improves the range of motion (ROM) in the knee joint after primary- or revision total knee arthroplasty (TKA) The main questions it aims to answer are:

• Does it make a difference to the ROM of the knee joint to do specific active exercise 2 times a day compared to 8 times a day in an 18 days period of time
• Analyze if range of motion in the knee joint after TKA has an impact on self-reported activity, pain and physical activity Participants will be instructed by a physiotherapist to do a specific exercise to improve the flexion of the knee-joint and and other to improve the extension of the knee-joint. One group will be instructed to do the exercises 2 times a day the other group to do the exercises 8 times a day in total of 18 days The two groups will be compared to see if there is an effect in ROM and if the effect is significant between the groups if the intervention is done 2 times versus 8 times a day.

Conditions

Total Knee Arthroplasty

Keywords

Range of motion; Physical therapy; Rehabilitation; Patient monitored exercises; Active mobilization exercises; Movement exercises; Mobility training; Mobility exercises; Flexion exercises; Stretching; Extension exercises; Movement therapy; Improved range of motion; ROM; Improved function; Active range of motion; Knee function; Active Range of movement

Outcome Measures

Primary Outcomes (1)

• Range of Motion in knee joint

  Active flexion and extension measured with goniometer by physiotherapist (normal Range of motion (normal 0-140 degrees)

  Day 1(baseline) and day 18

Secondary Outcomes (4)

• 6 minutes walk test

  Day 1(baseline) and day 18

• 30 seconds stand and sit test

  Day 1(baseline) and day 18

• Numerical Rating Scale (NRS)

  Day 1(baseline) and day 18

• The Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Day 1(baseline) and day 18

Study Arms (2)

Intervention with active exercises for knee joint 2 times a day

ACTIVE COMPARATOR

Intervention group A does 1 active exercise to improve flexion and 1 active exercise to improve extension 2 times a day, 18 days in a row

Behavioral: Exercise

Intervention with active exercises for knee joint 8 times a day

ACTIVE COMPARATOR

Intervention group B does 1 active exercise to improve flexion and 1 active exercise to improve extension 8 times a day, 18 days in a row

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Physiotherapeutic instructions to patients to do active exercise to improve the mobility of knee joint post-surgical

Intervention with active exercises for knee joint 2 times a day; Intervention with active exercises for knee joint 8 times a day

Eligibility Criteria

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

You may qualify if:

• Primary or revision total knee arthroplasty
• ° or less Flexion in knee joint;
• Last post operation date 6 weeks to 6 month

You may not qualify if:

• Unilateral arthroplasty in knee joint
• Other operations in knee joint than total knee arthroplasty
• Flexion in knee joint more than 105°
• Operation more than 6 month ago
• Randomizing: The visitation team assesses all referrals coming from doctors (orthopedic surgeons, general practitioners, private practice specialists) and accepts those patients for admission who are within the visitation guidelines. No members of the visitation have direct patient contact in relation to the training at Montebello. Patients are accepted through the Health Platform (SP) used in the Capital Region of Denmark.
• After visitation, secretaries will summon patients to planned knee teams on available dates. The secretaries are geographically located 3000 kilometers away from the department and have no knowledge of the research project. In chronological order, in relation to the time of visitation, patients will be summoned to a given date. As there can be a maximum of 11 patients on a given admission date, others awaiting admission will be allocated the next available date and so on.
• Due to the department's continuous reception of patients, where up to 11 knee patients are received in the same team on a given date, randomization cannot take place at a individual level but at team-level, so that patients hospitalized on the same date do not receive two different interventions since they train together during the 3 weeks.
• Whether a group of patients receives intervention with 2 repetitions or 8 is determined by a drawing by lot after joint measurement has been done. Therapists who will oversee treatment and instruction first learn whether the group should be instructed in 2 or 8 repetitions at the first group training. The same applies to the included patients.

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

Nordsjællands Hospital, Montebello

Hillerød, 3400, Denmark

Location

Related Publications (20)

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  PMID: 22357571 BACKGROUND

• Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.

  PMID: 15866968 BACKGROUND

• Silva M, Shepherd EF, Jackson WO, Pratt JA, McClung CD, Schmalzried TP. Knee strength after total knee arthroplasty. J Arthroplasty. 2003 Aug;18(5):605-11. doi: 10.1016/s0883-5403(03)00191-8.

  PMID: 12934213 BACKGROUND

• 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

• Mutsuzaki H, Takeuchi R, Mataki Y, Wadano Y. Target range of motion for rehabilitation after total knee arthroplasty. J Rural Med. 2017 May;12(1):33-37. doi: 10.2185/jrm.2923. Epub 2017 May 24.

  PMID: 28593015 BACKGROUND

• Matsuda S, Kawahara S, Okazaki K, Tashiro Y, Iwamoto Y. Postoperative alignment and ROM affect patient satisfaction after TKA. Clin Orthop Relat Res. 2013 Jan;471(1):127-33. doi: 10.1007/s11999-012-2533-y.

  PMID: 22903282 BACKGROUND

• Maloney WJ. The stiff total knee arthroplasty: evaluation and management. J Arthroplasty. 2002 Jun;17(4 Suppl 1):71-3. doi: 10.1054/arth.2002.32450.

  PMID: 12068410 BACKGROUND

• da Silva RR, Santos AA, de Sampaio Carvalho Junior J, Matos MA. Quality of life after total knee arthroplasty: systematic review. Rev Bras Ortop. 2014 Sep 19;49(5):520-7. doi: 10.1016/j.rboe.2014.09.007. eCollection 2014 Sep-Oct.

  PMID: 26229855 BACKGROUND

• Liao CD, Tsauo JY, Huang SW, Chen HC, Chiu YS, Liou TH. Preoperative range of motion and applications of continuous passive motion predict outcomes after knee arthroplasty in patients with arthritis. Knee Surg Sports Traumatol Arthrosc. 2019 Apr;27(4):1259-1269. doi: 10.1007/s00167-018-5257-z. Epub 2018 Dec 7.

  PMID: 30523369 BACKGROUND

• Sanchez Mayo B, Rodriguez-Mansilla J, Gonzalez Sanchez B. [Recovery from total knee arthroplasty through continuous passive motion]. An Sist Sanit Navar. 2015 May-Aug;38(2):297-310. doi: 10.23938/ASSN.0079. Spanish.

  PMID: 26486536 BACKGROUND

• Joshi RN, White PB, Murray-Weir M, Alexiades MM, Sculco TP, Ranawat AS. Prospective Randomized Trial of the Efficacy of Continuous Passive Motion Post Total Knee Arthroplasty: Experience of the Hospital for Special Surgery. J Arthroplasty. 2015 Dec;30(12):2364-9. doi: 10.1016/j.arth.2015.06.006. Epub 2015 Jun 14.

  PMID: 26165955 BACKGROUND

• Herbold JA, Bonistall K, Blackburn M, Agolli J, Gaston S, Gross C, Kuta A, Babyar S. Randomized controlled trial of the effectiveness of continuous passive motion after total knee replacement. Arch Phys Med Rehabil. 2014 Jul;95(7):1240-5. doi: 10.1016/j.apmr.2014.03.012. Epub 2014 Mar 28.

  PMID: 24685389 BACKGROUND

• Harvey LA, Brosseau L, Herbert RD. Continuous passive motion following total knee arthroplasty in people with arthritis. Cochrane Database Syst Rev. 2014 Feb 6;2014(2):CD004260. doi: 10.1002/14651858.CD004260.pub3.

  PMID: 24500904 BACKGROUND

• Boese CK, Weis M, Phillips T, Lawton-Peters S, Gallo T, Centeno L. The efficacy of continuous passive motion after total knee arthroplasty: a comparison of three protocols. J Arthroplasty. 2014 Jun;29(6):1158-62. doi: 10.1016/j.arth.2013.12.005. Epub 2013 Dec 14.

  PMID: 24412145 BACKGROUND

• Trzeciak T, Richter M, Ruszkowski K. [Effectiveness of continuous passive motion after total knee replacement]. Chir Narzadow Ruchu Ortop Pol. 2011 Nov-Dec;76(6):345-9. Polish.

  PMID: 22708322 BACKGROUND

• Bhave A, Sodhi N, Anis HK, Ehiorobo JO, Mont MA. Static progressive stretch orthosis-consensus modality to treat knee stiffness-rationale and literature review. Ann Transl Med. 2019 Oct;7(Suppl 7):S256. doi: 10.21037/atm.2019.06.55.

  PMID: 31728380 BACKGROUND

• Bade MJ, Stevens-Lapsley JE. Early high-intensity rehabilitation following total knee arthroplasty improves outcomes. J Orthop Sports Phys Ther. 2011 Dec;41(12):932-41. doi: 10.2519/jospt.2011.3734. Epub 2011 Sep 30.

  PMID: 21979411 BACKGROUND

• Mau-Moeller A, Behrens M, Finze S, Bruhn S, Bader R, Mittelmeier W. The effect of continuous passive motion and sling exercise training on clinical and functional outcomes following total knee arthroplasty: a randomized active-controlled clinical study. Health Qual Life Outcomes. 2014 May 9;12:68. doi: 10.1186/1477-7525-12-68.

  PMID: 24886619 BACKGROUND

• Papotto BA, Mills T. Treatment of severe flexion deficits following total knee arthroplasty: a randomized clinical trial. Orthop Nurs. 2012 Jan-Feb;31(1):29-34. doi: 10.1097/NOR.0b013e3182419662.

  PMID: 22278649 BACKGROUND

• Jakobsen TL, Christensen M, Christensen SS, Olsen M, Bandholm T. Reliability of knee joint range of motion and circumference measurements after total knee arthroplasty: does tester experience matter? Physiother Res Int. 2010 Sep;15(3):126-34. doi: 10.1002/pri.450.

  PMID: 20024893 BACKGROUND

Related Links

• Danish knee arthroplasty register (2019)
• Organization for Danish physiotherapists - measuring tools

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lisbeth Mogensen, cand.scient.

  Quality coordinator

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor: Have no knowledge of the intervention the individual patient has received Participant, are asked to join after they meet the criteria's for inclusion, they know what intervention they get but no knowledge of the intervention in the other group Care Provider - know at the time for the first intervention right after drawing number 2 or 8
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients admitted to the hospital because of a knee problem are assign to a date of hospitalizing in random order by the secretary. Once at the hospital the knee patients, who might be candidates for the enrollment of the study, will get the ROM of the knees measured by a blinded physiotherapist trained in measuring knee joint. After joint measuring, there will be held a drawing from a bag which contains equal numbers marked either with a 2 or 8. The number is only known by the principal investigator and the 2 therapist who will introduce the patients to the exercises and instruct in the daily interval of doing the exercises (2 or 8). The therapist invites the patients which meets the inclusion criteria to take part in the study. After 18 days of treatment the outcome assessors will once again measure the ROM on patients included in the study (same therapist that did the the first measuring of a specific patient)

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 3, 2024
• Study Start: October 29, 2022
• Primary Completion: April 6, 2024
• Study Completion: April 6, 2024
• Last Updated: May 23, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)