Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Total Enrollment
80 participants
Study Classification
OBSERVATIONAL
Study Start Date
2011-12-31
Study Completion Date
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Fast Track Recovery Arthroplasty Project is supposed to analyse a new medical method to accelerate patient's remobilisation process after total knee endoprostheses. The method, called c-treatment, is a computer-controlled cryotherapy (soothing cooling therapy) at which the device measures temperature at the affected site (the operated knee in the investigators investigation) and optimizes the cooling temperature. The optimized cooling therapy is supposed to reduce swelling and postoperative pain whereby patient's postoperative mobilization can be done earlier leading to a reduction of length of hospitalization.
To verify c-treatment's efficiency compared to conventional cryotherapy, patients are split in a test group and a standard group. The standard group is treated following the standard protocol at the Department of Orthopaedics Surgery Graz using cold packs (Fa. Dahlhausen, product code 93.000.00.042). Patient's in the test group receive c-treatment therapy following the study protocol.
All patients are instructed to fill in standardized questionnaires to evaluate social scores and pain scores preoperative as well as postoperative. The knee's swelling and range of motion as well as blood parameters monitoring the healing process are measured following the study protocol.
The comparison of these parameters between the standard and the test group is supposed to verify c-treatment's efficiency.
To verify c-treatment's efficiency compared to conventional cryotherapy, patients are split in a test group and a standard group. The standard group is treated following the standard protocol at the Department of Orthopaedics Surgery Graz using cold packs (Fa. Dahlhausen, product code 93.000.00.042). Patient's in the test group receive c-treatment therapy following the study protocol.
All patients are instructed to fill in standardized questionnaires to evaluate social scores and pain scores preoperative as well as postoperative. The knee's swelling and range of motion as well as blood parameters monitoring the healing process are measured following the study protocol.
The comparison of these parameters between the standard and the test group is supposed to verify c-treatment's efficiency.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Recovery After Fast Track THA / TKA
NCT02137655
Hip and Knee Osteoarthritis
COMPLETED
Reparel Knee Sleeve vs. TED Hose for Post-op Swelling, Pain and Range of Motion After Total Knee Replacement
NCT04751942
Osteoarthritis Knees Both
COMPLETED
NA
Swelling Management After Total Knee Arthroplasty
NCT04841356
Total Knee Arthroplasty
COMPLETED
NA
Rehabilitation After Fast-track Total Knee Arthroplasty
NCT01329081
Knee Arthroplasty
WITHDRAWN
NA
Evaluation of a Fast-track Knee Arthroplasty Concept
NCT03114306
Knee Arthropathy
Postoperative Pain
Postoperative Complications
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
OBJECTIVES
The purpose of this prospective, randomized, single-blind, comparative and controlled clinical study was to evaluate a new cryotherapy device, the cTreatment® system (Waegener®, Belgium) consisting of the Cryoceutical Treatment Server 100 series (CTS) and the Cryoceutical Treatment Pad (cPad®), in comparison to the standard cooling protocol, which was the cold packs (cold/hot pack, Dahlhausen®) currently used at the Department of Orthopaedic Surgery of the Medical University of Graz, Austria, in patients undergoing primary and unilateral TKA surgery. It was particularly focused on the device's efficiency in terms of eventual improvements in the patient's postoperative rehabilitation and mobilisation, such as positive alterations of knee ROM and NRS pain scale, which were set as primary objectives. Further contributing elements, such as alterations of the analgesic consumption, knee girth and the device's safety were set as secondary objectives.
METHODS
Subjects between 18 and 90 suffering from severe degeneratively or traumatically caused gonarthritis or gonarthrosis of the knee joint scheduled for endoprothetic treatment with TKA could be included when giving their informed consent. Exclusion criteria particularly included, on the one side, reasons, which might interfere with the patients' statistical comparability regarding the outcome, such as severe pre-existing local and systemic conditions others than gonarthritis and foregone surgical interventions others than arthroscopy. On the other side it contained conditions, which would interfere with the planned study design, for instance, the standardized medication and PCA and long cooling intervals during hospitalisation.
After giving their written consent they were further randomized to the cryotherapy group, receiving the cTreatment®, or the standard group, receiving cold pack application. Therefore a web-based programme, the "Randomizer", was used (23), considering the patient's sex and scheduled design type of endoprostheses to be implanted, which was either the PFC® or the LCS® (both from DePuy®, Warsaw, IN, USA) endoprosthesis.
After being randomized to the therapy group patients were assigned to the locally applied cryotherapy treatment by use of the cTreatment® system until the end of the clinical study, which was set for POD six. That implied the first cooling session to the extent of one hour already preoperatively on the first preoperative day (PreOD), which coincidently was the day of admission throughout all cases. Furthermore, the subjects received cryotherapy immediately after TKA in the postanaesthesia care unit for six hours in total. During the in-patient setting until POD six the cTreatment® was applied each day for four hours in total, divided into two hours in the morning and two hours in the afternoon. Also there was the option to use the cTreatment® in terms of additional analgesia in the evening for up to four hours on each POD.
PreOD 1 TKA POD 1 POD 2 POD 3 POD 4 POD 5 POD 6
* 1 h pre-OP 6 h post-OP
4 h optional 2 h morning
2 h afternoon
4 h optional 2 h morning
2 h afternoon
4 h optional 2 h morning
2 h afternoon
4 h optional 2 h morning
2 h afternoon
4 h optional 2 h morning
2 h afternoon
4 h optional 2 h morning
2 h afternoon
4 h optional Table 1: cTreatment® protocol in therapy group
According to the manufacturer, the CTS is a class IIa medical device, which thermodynamically exchanges heat controlled by a built-in computer. It is able to regulate both the flow rate and the fluid's temperature reaching the cPad®. The CTS is operated by use of a touch screen, which allows to start, pause, resume and stop a cooling session. According to the instruction manual the cPad®, which is connected to the Server with flexible tubes using anti-reflux design, is made of flexible Polyurethane, latex free and hypoallergenic. Using hook and loop fasteners it is easy to wrap around the knee ensuring a maximum of contact surface.
The control group was treated abiding by the standard cryotherapy regimen at the Department of Orthopaedic Surgery including the usage of common cold packs (cold/hot pack, Dahlhausen®). They did not receive any cryotherapy before the surgical intervention corresponding to the standard regimen. After TKA cold packs were applied three times per day for 20 minutes each throughout the whole trial. In the context of blinding, the cold packs were placed beneath the applied cPads® in subjects randomized to the standard group, in order to account for a subjectively experienced cold as the CTS was turned off. Besides that, the study setting was identical in both groups.
For the purpose of a better comparability all participating patients received general anaesthesia and a postoperative analgetic therapy based on patient controlled analgesia (PCA), which was filled with diluted hydromorphone, accounting for 0,2 mg hydromorphone per single dose. In addition to that, exclusively Novalgin® 4 x 1 g was administered as a non-opiate analgesic. The PCA was removed after 72 hours postoperative.
The performed physical measurements consisted of the quantification of the knee girth and the ROM of the treated knee joint. The measurements concerning the knee girth were performed at three different levels, at middle-patella, 7 centimetres proximal of the patellar base and 7 centimetres distal of the apex patellae. The ROM was evaluated by use of a hand-held goniometer and the patient being in a supine position. Among the non-physical evaluations was verbally assessing the subjectively experienced pain intensity by use of the eleven-point numeric rating scale (NRS) pain score, about which each patients was told that zero was equal to "no pain at all" and ten was equal to "strongest pain imaginable". The NRS was always evaluated for the state of absolute rest and the state of motion. In this relation the more objectively evaluable analgesics consumption was recorded. Therefore the total hydromorphone usage administered by use of PCA after 72 hours was noted. The physical examinations of the knee joint's ROM and girth and the NRS score evaluation were performed on admission day and POD two, four and six. In the course of the regular change of dressings during the medical rounds the surgical area was exactly examined for potential cold-induced local alterations. In this context, it was particularly searched for signs of frostbite, nerve palsy, inhibited wound healing, deep vein thrombosis and infection. In case of occurrence, the patients had also been told to immediately call attention to eventual adverse effects related to the cold therapy, which they were preliminarily informed about.
IBM® SPSS® Statistics software version 20 was used in order to perform all statistical analyses. In this regard descriptive statistics were conducted using basic calculations of means, standard deviations, ranges, minima and maxima. For the comparisons between the two study groups on admission day, POD two, four and six measured data was first checked for the existence of normal distribution by use of Shapiro-Wilk and Kolmogorov- Smirnov tests. In case of normal distribution, the independent-samples t-test as parametric test was performed. If a normal distribution did not exist, the Wilcoxon-Mann-Whitney test as non-parametric test was performed in order to obtain values of significance regarding between-group distinctions. Throughout the statistical analyses, the level of significance, respectively the P-value was defined as ≤ 0,05.
The purpose of this prospective, randomized, single-blind, comparative and controlled clinical study was to evaluate a new cryotherapy device, the cTreatment® system (Waegener®, Belgium) consisting of the Cryoceutical Treatment Server 100 series (CTS) and the Cryoceutical Treatment Pad (cPad®), in comparison to the standard cooling protocol, which was the cold packs (cold/hot pack, Dahlhausen®) currently used at the Department of Orthopaedic Surgery of the Medical University of Graz, Austria, in patients undergoing primary and unilateral TKA surgery. It was particularly focused on the device's efficiency in terms of eventual improvements in the patient's postoperative rehabilitation and mobilisation, such as positive alterations of knee ROM and NRS pain scale, which were set as primary objectives. Further contributing elements, such as alterations of the analgesic consumption, knee girth and the device's safety were set as secondary objectives.
METHODS
Subjects between 18 and 90 suffering from severe degeneratively or traumatically caused gonarthritis or gonarthrosis of the knee joint scheduled for endoprothetic treatment with TKA could be included when giving their informed consent. Exclusion criteria particularly included, on the one side, reasons, which might interfere with the patients' statistical comparability regarding the outcome, such as severe pre-existing local and systemic conditions others than gonarthritis and foregone surgical interventions others than arthroscopy. On the other side it contained conditions, which would interfere with the planned study design, for instance, the standardized medication and PCA and long cooling intervals during hospitalisation.
After giving their written consent they were further randomized to the cryotherapy group, receiving the cTreatment®, or the standard group, receiving cold pack application. Therefore a web-based programme, the "Randomizer", was used (23), considering the patient's sex and scheduled design type of endoprostheses to be implanted, which was either the PFC® or the LCS® (both from DePuy®, Warsaw, IN, USA) endoprosthesis.
After being randomized to the therapy group patients were assigned to the locally applied cryotherapy treatment by use of the cTreatment® system until the end of the clinical study, which was set for POD six. That implied the first cooling session to the extent of one hour already preoperatively on the first preoperative day (PreOD), which coincidently was the day of admission throughout all cases. Furthermore, the subjects received cryotherapy immediately after TKA in the postanaesthesia care unit for six hours in total. During the in-patient setting until POD six the cTreatment® was applied each day for four hours in total, divided into two hours in the morning and two hours in the afternoon. Also there was the option to use the cTreatment® in terms of additional analgesia in the evening for up to four hours on each POD.
PreOD 1 TKA POD 1 POD 2 POD 3 POD 4 POD 5 POD 6
* 1 h pre-OP 6 h post-OP
4 h optional 2 h morning
2 h afternoon
4 h optional 2 h morning
2 h afternoon
4 h optional 2 h morning
2 h afternoon
4 h optional 2 h morning
2 h afternoon
4 h optional 2 h morning
2 h afternoon
4 h optional 2 h morning
2 h afternoon
4 h optional Table 1: cTreatment® protocol in therapy group
According to the manufacturer, the CTS is a class IIa medical device, which thermodynamically exchanges heat controlled by a built-in computer. It is able to regulate both the flow rate and the fluid's temperature reaching the cPad®. The CTS is operated by use of a touch screen, which allows to start, pause, resume and stop a cooling session. According to the instruction manual the cPad®, which is connected to the Server with flexible tubes using anti-reflux design, is made of flexible Polyurethane, latex free and hypoallergenic. Using hook and loop fasteners it is easy to wrap around the knee ensuring a maximum of contact surface.
The control group was treated abiding by the standard cryotherapy regimen at the Department of Orthopaedic Surgery including the usage of common cold packs (cold/hot pack, Dahlhausen®). They did not receive any cryotherapy before the surgical intervention corresponding to the standard regimen. After TKA cold packs were applied three times per day for 20 minutes each throughout the whole trial. In the context of blinding, the cold packs were placed beneath the applied cPads® in subjects randomized to the standard group, in order to account for a subjectively experienced cold as the CTS was turned off. Besides that, the study setting was identical in both groups.
For the purpose of a better comparability all participating patients received general anaesthesia and a postoperative analgetic therapy based on patient controlled analgesia (PCA), which was filled with diluted hydromorphone, accounting for 0,2 mg hydromorphone per single dose. In addition to that, exclusively Novalgin® 4 x 1 g was administered as a non-opiate analgesic. The PCA was removed after 72 hours postoperative.
The performed physical measurements consisted of the quantification of the knee girth and the ROM of the treated knee joint. The measurements concerning the knee girth were performed at three different levels, at middle-patella, 7 centimetres proximal of the patellar base and 7 centimetres distal of the apex patellae. The ROM was evaluated by use of a hand-held goniometer and the patient being in a supine position. Among the non-physical evaluations was verbally assessing the subjectively experienced pain intensity by use of the eleven-point numeric rating scale (NRS) pain score, about which each patients was told that zero was equal to "no pain at all" and ten was equal to "strongest pain imaginable". The NRS was always evaluated for the state of absolute rest and the state of motion. In this relation the more objectively evaluable analgesics consumption was recorded. Therefore the total hydromorphone usage administered by use of PCA after 72 hours was noted. The physical examinations of the knee joint's ROM and girth and the NRS score evaluation were performed on admission day and POD two, four and six. In the course of the regular change of dressings during the medical rounds the surgical area was exactly examined for potential cold-induced local alterations. In this context, it was particularly searched for signs of frostbite, nerve palsy, inhibited wound healing, deep vein thrombosis and infection. In case of occurrence, the patients had also been told to immediately call attention to eventual adverse effects related to the cold therapy, which they were preliminarily informed about.
IBM® SPSS® Statistics software version 20 was used in order to perform all statistical analyses. In this regard descriptive statistics were conducted using basic calculations of means, standard deviations, ranges, minima and maxima. For the comparisons between the two study groups on admission day, POD two, four and six measured data was first checked for the existence of normal distribution by use of Shapiro-Wilk and Kolmogorov- Smirnov tests. In case of normal distribution, the independent-samples t-test as parametric test was performed. If a normal distribution did not exist, the Wilcoxon-Mann-Whitney test as non-parametric test was performed in order to obtain values of significance regarding between-group distinctions. Throughout the statistical analyses, the level of significance, respectively the P-value was defined as ≤ 0,05.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Swelling
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
c-treatment
test group
No interventions assigned to this group
standard cooling
comparison group
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* degenerative or posttraumatic gonarthrosis or osteonecrosis around the knee
* scheduled operation for total knee endoprosthesis
* age between 18 and 90 years
* patient agrees with study design, therapy and postoperative controls
* education form is signed by patient and physician
* scheduled operation for total knee endoprosthesis
* age between 18 and 90 years
* patient agrees with study design, therapy and postoperative controls
* education form is signed by patient and physician
Exclusion Criteria
* Body Mass Index greater than 40
* varus or valgus deformity greater than 10 degrees
* impaired extension greater than 10 degrees
* flexion preoperative less than 90 degrees
* cold urticaria
* cryoglobulinemia
* paroxysmal cold hemoglobinuria
* current fracture around the knee
* current infection or status post infection
* rheumatoid arthritis at knee
* tumor around the knee
* any operations done around the knee except arthroscopic knee surgery
* active systemic infection (HIV, HBV, HCV)
* obstructive sleep apnea
* opioid intolerance
* incompliance concerning patient controlled analgesia
* cold allergy or cold intolerance
* Raynaud's Disease
* circulatory disorder at the affected leg
* fibromyalgia or other chronic pain syndromes
* taking of immune modulating medication as cortisone, interferon or similar
* depression or anxiety disorder
* addicted to drugs or alcohol
* pregnancy or possible pregnancy without adequate contraception
* no signed education form
* unsoundness of mind
* varus or valgus deformity greater than 10 degrees
* impaired extension greater than 10 degrees
* flexion preoperative less than 90 degrees
* cold urticaria
* cryoglobulinemia
* paroxysmal cold hemoglobinuria
* current fracture around the knee
* current infection or status post infection
* rheumatoid arthritis at knee
* tumor around the knee
* any operations done around the knee except arthroscopic knee surgery
* active systemic infection (HIV, HBV, HCV)
* obstructive sleep apnea
* opioid intolerance
* incompliance concerning patient controlled analgesia
* cold allergy or cold intolerance
* Raynaud's Disease
* circulatory disorder at the affected leg
* fibromyalgia or other chronic pain syndromes
* taking of immune modulating medication as cortisone, interferon or similar
* depression or anxiety disorder
* addicted to drugs or alcohol
* pregnancy or possible pregnancy without adequate contraception
* no signed education form
* unsoundness of mind
Minimum Eligible Age
18 Years
Maximum Eligible Age
90 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of Graz
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mathias Glehr, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Orthopaedics Surgery Graz - Medical University Graz
Graz, , Austria
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Austria
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Herbold JA, Bonistall K, Walsh MB. Rehabilitation following total knee replacement, total hip replacement, and hip fracture: a case-controlled comparison. J Geriatr Phys Ther. 2011 Oct-Dec;34(4):155-60. doi: 10.1519/JPT.0b013e318216db81.
Reference Type
BACKGROUND
Bade MJ, Kohrt WM, Stevens-Lapsley JE. Outcomes before and after total knee arthroplasty compared to healthy adults. J Orthop Sports Phys Ther. 2010 Sep;40(9):559-67. doi: 10.2519/jospt.2010.3317.
Reference Type
BACKGROUND
Sultan PG, Most E, Schule S, Li G, Rubash HE. Optimizing flexion after total knee arthroplasty: advances in prosthetic design. Clin Orthop Relat Res. 2003 Nov;(416):167-73. doi: 10.1097/01.blo.0000081937.75404.ee.
Reference Type
BACKGROUND
Markert SE. The use of cryotherapy after a total knee replacement: a literature review. Orthop Nurs. 2011 Jan-Feb;30(1):29-36. doi: 10.1097/NOR.0b013e318205749a.
Reference Type
BACKGROUND
Adie S, Naylor JM, Harris IA. Cryotherapy after total knee arthroplasty a systematic review and meta-analysis of randomized controlled trials. J Arthroplasty. 2010 Aug;25(5):709-15. doi: 10.1016/j.arth.2009.07.010. Epub 2009 Sep 2.
Reference Type
BACKGROUND
Holmstrom A, Hardin BC. Cryo/Cuff compared to epidural anesthesia after knee unicompartmental arthroplasty: a prospective, randomized and controlled study of 60 patients with a 6-week follow-up. J Arthroplasty. 2005 Apr;20(3):316-21. doi: 10.1016/j.arth.2004.09.043.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FARP24-214
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Fast-Track vs Conventional for UKA
NCT00284635
COMPLETED
PHASE4
Length of Stay and Complications in High-risk Patients Receiving Fast-track Total Hip (THA) or Knee- Alloplasty (TKA)
NCT01515670
COMPLETED
Improvement in Wound Healing With Negative Pressure Wound Therapy for Postoperative Total Hip Arthroplasty
NCT02355691
TERMINATED
NA
Frequency of Vascular Events With Short-term Thromboprophylaxis in Fast-track Hip and Knee-arthroplasty.
NCT01557725
COMPLETED
Implementation of a Rapid Recovery Protocol in Total Knee Arthroplasty
NCT03823573
COMPLETED
NA
The Fast-track Centre for Hip and Knee Replacement Database
NCT05613439
RECRUITING
Postoperative Sleep Disturbances After Fast Track Hip and Knee Replacement
NCT01144130
COMPLETED
SPECT-CT for Assessment of Total Knee Arthroplasty in Navigated and Non-navigated Total Knee Arthroplasty
NCT02358447
COMPLETED
Fluoroscopic Analysis of Total Knee Replacement With a Kinematic Retaining or a Posterior Stabilized Design
NCT02706990
COMPLETED
NA
The Use of the GRASP System for Postoperative Monitoring
NCT06825988
COMPLETED
EARLY_PHASE1
Total Knee Arthroplasty: Fast Track Protocol is the Future?
NCT03869996
RECRUITING
NA
Out Patient Surgery for Total Knee and Hip Replacement and Unicompartmental Knee Replacement - a Feasibility Study
NCT02544620
COMPLETED
Home Rehabilitation Using Interactive Device Versus Inpatient Rehabilitation in Total Knee Arthroplasty
NCT03476148
UNKNOWN
NA
Investigation of Knee Hyperextension and Femoral Cartilage Thickness in Chronic Stroke Patients
NCT05513157
COMPLETED
In-vivo Comparison of Different Levels of Femoral Rollback in a Primary Total Knee Arthroplasty
NCT02251535
UNKNOWN
NA
Fast-track Rehabilitation After Total Knee or Hip Arthroplasty
NCT03035435
COMPLETED
Evaluating Advantages of Prevena After Hip and Knee Arthroplasty
NCT01854138
COMPLETED
NA
Comparison of Three Tourniquet Application Methods in Primary Total Knee Arthroplasty Surgery
NCT01355900
COMPLETED
NA
Biochemical Approach to Measuring Surgical Trauma
NCT01037400
WITHDRAWN
Telerehabilitation After Total Knee Arthroplasty
NCT04923373
COMPLETED
NA
Routine Use of Negative Pressure Wound Therapy THR TKR RCT
NCT06181097
RECRUITING
NA
Effect of Tourniquet Application on Postoperative Functional Outcome Following Total Knee Arthroplasty
NCT02308410
COMPLETED
A Prospective Clinical Study On A Total Hip Resurfacing System
NCT00603395
COMPLETED
NA
Physiotherapy for Arthrofibrosis Following Knee Replacement.
NCT05459259
UNKNOWN
Early Migration in a High Congruent Rotating Platform Total Knee Prosthesis Design
NCT01102829
COMPLETED