Osteoarthritis, KneeNCT02516280
Effects of Gaseous Cryotherapy on Knee ROM After TKA: A Feasibility Study
A study testing Cryoton ™ in people with Osteoarthritis, Knee, run by Centre Hospitalier de Verdun.
Trial summary
A pilot study was performed to investigate the feasibility of a large randomized controlled trial (RCT) to assess the effects of hyperbaric gaseous cryotherapy (HGC) on the change in knee flexion range of motion in the first two days after total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 35 to 79 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Cryoton ™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned unilateral TKA done at Verdun Hospital.
- Capacity to communicate in French or English.
Who cannot join
- Complications during or after the surgery.
- Inability to perform the tests due to other diseases.
- Contraindications to cryotherapy such as Raynaud's disease, cryoglobulinemia, hemoglobinopathy, polyneuropathy associated with temperature sensitivity deficits or allergy to cold.
About this study
Official title: Effects of Hyperbaric Gaseous Cryotherapy on Knee Flexion Range of Motion in the First Two Days After Total Knee Arthroplasty: A Feasibility Randomized Controlled Trial
A pilot study was performed to investigate the feasibility of a large randomized controlled trial (RCT) to assess the effects of hyperbaric gaseous cryotherapy (HGC) on the change in knee flexion range of motion in the first two days after total knee arthroplasty.
Read the detailed description
Background: After total knee arthroplasty (TKA), patients can be discharged from hospital as early as two days after surgery. However, patients often do not achieve functional knee flexion range of motion (ROM) in the first postoperative days. Early application of hyperbaric gaseous cryotherapy (HGC) at the operated knee within an hour after surgery and the next postoperative days might increase ROM by reducing inflammation, edema and pain. However, it is unclear whether such early application of HGC is feasible. Moreover, there is no data to allow calculation of the sample size required to conduct a randomized controlled trial to compare the effects of HGC to those of conventional cryotherapy on the increase of knee flexion in the first two days after TKA.
Objectives: To investigate the feasibility of applying HGC within an hour after TKA and twice a day the next postoperative days. To collect data on changes in knee flexion ROM in the first two postoperative days to calculate the sample size required for a large randomized controlled trial. To compare the effects of HGC to those of conventional cryotherapy on changes in knee flexion ROM in the first two postoperative days.
Design: A prospective, single-blinded, randomized, controlled pilot trial.
Setting: Orthopedic postoperative unit in an acute care hospital.
Interventions: Patients were randomly allocated to either hyperbaric gaseous cryotherapy (intervention group) or the ice bag cryotherapy (control group). In each group, participants received the specific cryotherapy intervention at the operated knee within an hour after the surgery (day 0) and twice the next two postoperative days (day 1 and day 2).
Outcome measures: Feasibility measures included the rate of eligible patients who were willing to participate, attrition, adherence to interventions and presence of adverse effects. Active and passive knee flexion range of motion (ROM) and knee pain intensity at rest were evaluated on postoperative days 1 and 2. Change in active and passive knee flexion ROM and in knee pain intensity at rest from postoperative day 1 to day 2 were assessed. Length of hospital stay was collected.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Cryoton ™, Control ice bag
- Keywords
- Total knee replacement, Cold, Neurocryostimulation, CO2 cryotherapy, mobility
- Medical subject headings
- Osteoarthritis, Knee, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoton ™Device
Also called Neurocryostimulation, Cryonic
In the intervention group, participants received hyperbaric gaseous cryotherapy delivered with a Cryoton ™ device (Cryonic Médical, Salins-les-Bains, France) within an hour after the surgery and two times per day the next postoperative days. The tip of the nozzle was kept 10-15 cm above the dry skin as the gaseous CO2 was sprayed on three zones of 5 cm by 10 cm (medial, lateral and posterior, respectively) using a slow and regular sweeping movement for approximately 30 seconds after a skin temperature of 2°C is reached.
Control ice bagDevice
Also called ice
In the control group, participants received two 20-minute treatments of cryotherapy within an hour after the surgery and two times per day the next postoperative days. Cryotherapy was performed using an ice bag that was applied directly on the anterior aspect of the knee. The ice bag is a square latex bag of 30 cm by 30 cm filled with crushed ice and wrapped in a thin pillow case. The treatment assessor applied the intervention in a standardized manner by ensuring that the knee was fully extended while covering the surgical incision and both lateral and medial aspects of the knee with the iced bag.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric gaseous cryotherapy group | Experimental | Conventional rehabilitation with Cryoton ™ hyperbaric cryotherapy Receives: Device: Cryoton ™ |
| Control ice bag group | Active comparator | Conventional rehabilitation with ice bag cryotherapy. Application of a bag of crushed ice directly on the anterior aspect of the knee. Receives: Device: Control ice bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in active and passive knee flexion ROM measured by analysis.
The primary outcomes were changes in active and passive knee flexion ROM from postoperative day 1 to day 2. This outcome was calculated as the difference in active and passive ROM between day 2 and day 1
Measured: Between post-operative day 1 and 2
Secondary outcomes (6)
Active and passive knee flexion ROM measured using goniometry.
Active and passive knee flexion ROMs were measured with a long-arm (35 cm) goniometer featuring a 360º and two 180º scales, with 1º increments that read in opposite directions (Baseline 360° 14" Goniometer, Fabrication enterprises Inc., NY, USA). Knee ROMs were measured in sitting position because levels of agreement between observers are higher in sitting position than in supine position.
Measured: During the first 2 days after surgery.
Knee pain measured by visual analog scale.
Scale from 0 to 10 cm on a ruler where 0 represented no pain and 10 represented the worst pain imaginable.
Measured: During the first 2 days after surgery.
Change in pain from postoperative day 1 to day 2 measured by analysis of variation of the recorded pain between data of day2 and day 1 (Knee pain measured by visual analog scale)
Calculated as the difference of pain between day 2 and day 1.
Measured: Between day 1 and 2.
Feasibility was assessed by analysis of presence of adverse effects.
Determine if the patients where having or not adverse during thier stay.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days.
Feasibility was assessed by adherence to the intervention (attrition).
Determine if the patients where adhering to treatment (drop-off).
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days.
Length of the stay in hospital ward was measured by the length(in days) of inpatient episode of care.
Length of stay in hospital ward.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startJan 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (58)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Verdun
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal
- Responsible party
- Sponsor
- Investigators
- David Moreau, MSc, Principal investigator, Centre Hospitalier de Verdun
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516280
- Sponsor's protocol ID
- CHV2012-01
- Status last verified
- Aug 2015
- First submitted
- 27 Jul 2015
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Abramson DI, Chu LS, Tuck S Jr, Lee SW, Richardson G, Levin M. Effect of tissue temperatures and blood flow on motor nerve conduction velocity. JAMA. 1966 Dec 5;198(10):1082-8. No abstract available.
PubMed 5953385Adie S, Kwan A, Naylor JM, Harris IA, Mittal R. Cryotherapy following total knee replacement. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD007911. doi: 10.1002/14651858.CD007911.pub2.
PubMed 22972114Adie 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.
PubMed 19729279Alcelik I, Sukeik M, Pollock R, Misra A, Shah P, Armstrong P, Dhebar MI. Comparison of the minimally invasive and standard medial parapatellar approaches for primary total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2502-12. doi: 10.1007/s00167-012-1944-3. Epub 2012 Mar 15.
PubMed 22419264Ayalon O, Liu S, Flics S, Cahill J, Juliano K, Cornell CN. A multimodal clinical pathway can reduce length of stay after total knee arthroplasty. HSS J. 2011 Feb;7(1):9-15. doi: 10.1007/s11420-010-9164-1. Epub 2010 May 22.
PubMed 22294952Bade MJ, Kittelson JM, Kohrt WM, Stevens-Lapsley JE. Predicting functional performance and range of motion outcomes after total knee arthroplasty. Am J Phys Med Rehabil. 2014 Jul;93(7):579-85. doi: 10.1097/PHM.0000000000000065.
PubMed 24508937Bade 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.
PubMed 20710093Basso DM, Knapp L. Comparison of two continuous passive motion protocols for patients with total knee implants. Phys Ther. 1987 Mar;67(3):360-3. doi: 10.1093/ptj/67.3.360.
PubMed 3823150Belitsky RB, Odam SJ, Hubley-Kozey C. Evaluation of the effectiveness of wet ice, dry ice, and cryogenic packs in reducing skin temperature. Phys Ther. 1987 Jul;67(7):1080-4. doi: 10.1093/ptj/67.7.1080.
PubMed 3602101Bonutti PM, Mont MA, Kester MA. Minimally invasive total knee arthroplasty: a 10-feature evolutionary approach. Orthop Clin North Am. 2004 Apr;35(2):217-26. doi: 10.1016/j.ocl.2004.02.001.
PubMed 15062707Chatap G, De Sousa A, Giraud K, Vincent JP; Acute Pain in the Elderly Study Group. Pain in the elderly: Prospective study of hyperbaric CO2 cryotherapy (neurocryostimulation). Joint Bone Spine. 2007 Dec;74(6):617-21. doi: 10.1016/j.jbspin.2006.10.011. Epub 2007 Jul 19.
PubMed 17897861Cheng T, Liu T, Zhang G, Peng X, Zhang X. Does minimally invasive surgery improve short-term recovery in total knee arthroplasty? Clin Orthop Relat Res. 2010 Jun;468(6):1635-48. doi: 10.1007/s11999-010-1285-9. Epub 2010 Mar 13.
PubMed 20229136Chesterton LS, Foster NE, Ross L. Skin temperature response to cryotherapy. Arch Phys Med Rehabil. 2002 Apr;83(4):543-9. doi: 10.1053/apmr.2002.30926.
PubMed 11932859Chiu KY, Ng TP, Tang WM, Yau WP. Review article: knee flexion after total knee arthroplasty. J Orthop Surg (Hong Kong). 2002 Dec;10(2):194-202. doi: 10.1177/230949900201000215.
PubMed 12493934Ciolek JJ. Cryotherapy. Review of physiological effects and clinical application. Cleve Clin Q. 1985 Summer;52(2):193-201. doi: 10.3949/ccjm.52.2.193. No abstract available.
PubMed 3896574
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hyperbaric Gaseous Cryotherapy on Knee Flexion Range of Motion in the First Two Days After Total Knee Arthroplasty: A Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02516280
- Acronym / sponsor ID
- CHV2012-01
- Conditions
- Osteoarthritis, Knee
- Keywords
- Total knee replacement, Cold, Neurocryostimulation, CO2 cryotherapy, mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Centre Hospitalier de VerdunUniversity, hospital or other
- Collaborators
- Université de Montréal
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 5 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot study was performed to investigate the feasibility of a large randomized controlled trial (RCT) to assess the effects of hyperbaric gaseous cryotherapy (HGC) on the change in knee flexion range of motion in the first two days after total knee arthroplasty.
Detailed description
Background: After total knee arthroplasty (TKA), patients can be discharged from hospital as early as two days after surgery. However, patients often do not achieve functional knee flexion range of motion (ROM) in the first postoperative days. Early application of hyperbaric gaseous cryotherapy (HGC) at the operated knee within an hour after surgery and the next postoperative days might increase ROM by reducing inflammation, edema and pain. However, it is unclear whether such early application of HGC is feasible. Moreover, there is no data to allow calculation of the sample size required to conduct a randomized controlled trial to compare the effects of HGC to those of conventional cryotherapy on the increase of knee flexion in the first two days after TKA.
Objectives: To investigate the feasibility of applying HGC within an hour after TKA and twice a day the next postoperative days. To collect data on changes in knee flexion ROM in the first two postoperative days to calculate the sample size required for a large randomized controlled trial. To compare the effects of HGC to those of conventional cryotherapy on changes in knee flexion ROM in the first two postoperative days.
Design: A prospective, single-blinded, randomized, controlled pilot trial.
Setting: Orthopedic postoperative unit in an acute care hospital.
Interventions: Patients were randomly allocated to either hyperbaric gaseous cryotherapy (intervention group) or the ice bag cryotherapy (control group). In each group, participants received the specific cryotherapy intervention at the operated knee within an hour after the surgery (day 0) and twice the next two postoperative days (day 1 and day 2).
Outcome measures: Feasibility measures included the rate of eligible patients who were willing to participate, attrition, adherence to interventions and presence of adverse effects. Active and passive knee flexion range of motion (ROM) and knee pain intensity at rest were evaluated on postoperative days 1 and 2. Change in active and passive knee flexion ROM and in knee pain intensity at rest from postoperative day 1 to day 2 were assessed. Length of hospital stay was collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric gaseous cryotherapy group | Experimental | Device: Cryoton ™Conventional rehabilitation with Cryoton ™ hyperbaric cryotherapy |
| Control ice bag group | Active comparator | Device: Control ice bagConventional rehabilitation with ice bag cryotherapy. Application of a bag of crushed ice directly on the anterior aspect of the knee. |
Who may qualify
- Ages
- 35 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planned unilateral TKA done at Verdun Hospital.
- Capacity to communicate in French or English.
Key exclusion criteria (3 listed)
- Complications during or after the surgery.
- Inability to perform the tests due to other diseases.
- Contraindications to cryotherapy such as Raynaud's disease, cryoglobulinemia, hemoglobinopathy, polyneuropathy associated with temperature sensitivity deficits or allergy to cold.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoton ™Also: Neurocryostimulation, CryonicIn the intervention group, participants received hyperbaric gaseous cryotherapy delivered with a Cryoton ™ device (Cryonic Médical, Salins-les-Bains, France) within an hour after the surgery and two times per day the next postoperative days. The tip of the nozzle was kept 10-15 cm above the dry skin as the gaseous CO2 was sprayed on three zones of 5 cm by 10 cm (medial, lateral and posterior, respectively) using a slow and regular sweeping movement for approximately 30 seconds after a skin temperature of 2°C is reached. | Device | Hyperbaric gaseous cryotherapy group |
| Control ice bagAlso: iceIn the control group, participants received two 20-minute treatments of cryotherapy within an hour after the surgery and two times per day the next postoperative days. Cryotherapy was performed using an ice bag that was applied directly on the anterior aspect of the knee. The ice bag is a square latex bag of 30 cm by 30 cm filled with crushed ice and wrapped in a thin pillow case. The treatment assessor applied the intervention in a standardized manner by ensuring that the knee was fully extended while covering the surgical incision and both lateral and medial aspects of the knee with the iced bag. | Device | Control ice bag group |
Primary outcome
Changes in active and passive knee flexion ROM measured by analysis.
Time frame: Between post-operative day 1 and 2
The primary outcomes were changes in active and passive knee flexion ROM from postoperative day 1 to day 2. This outcome was calculated as the difference in active and passive ROM between day 2 and day 1
6 secondary outcomes
Active and passive knee flexion ROM measured using goniometry.
Time frame: During the first 2 days after surgery.
Knee pain measured by visual analog scale.
Time frame: During the first 2 days after surgery.
Change in pain from postoperative day 1 to day 2 measured by analysis of variation of the recorded pain between data of day2 and day 1 (Knee pain measured by visual analog scale)
Time frame: Between day 1 and 2.
Feasibility was assessed by analysis of presence of adverse effects.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days.
Feasibility was assessed by adherence to the intervention (attrition).
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days.
Length of the stay in hospital ward was measured by the length(in days) of inpatient episode of care.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
- Background: PubMed 5953385Abramson DI, Chu LS, Tuck S Jr, Lee SW, Richardson G, Levin M. Effect of tissue temperatures and blood flow on motor nerve conduction velocity. JAMA. 1966 Dec 5;198(10):1082-8. No abstract available.
- Background: PubMed 22972114Adie S, Kwan A, Naylor JM, Harris IA, Mittal R. Cryotherapy following total knee replacement. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD007911. doi: 10.1002/14651858.CD007911.pub2.
- Background: PubMed 19729279Adie 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.
- Background: PubMed 22419264Alcelik I, Sukeik M, Pollock R, Misra A, Shah P, Armstrong P, Dhebar MI. Comparison of the minimally invasive and standard medial parapatellar approaches for primary total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2502-12. doi: 10.1007/s00167-012-1944-3. Epub 2012 Mar 15.
- Background: PubMed 22294952Ayalon O, Liu S, Flics S, Cahill J, Juliano K, Cornell CN. A multimodal clinical pathway can reduce length of stay after total knee arthroplasty. HSS J. 2011 Feb;7(1):9-15. doi: 10.1007/s11420-010-9164-1. Epub 2010 May 22.
- Background: PubMed 24508937Bade MJ, Kittelson JM, Kohrt WM, Stevens-Lapsley JE. Predicting functional performance and range of motion outcomes after total knee arthroplasty. Am J Phys Med Rehabil. 2014 Jul;93(7):579-85. doi: 10.1097/PHM.0000000000000065.
- Background: PubMed 20710093Bade 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.
- Background: PubMed 3823150Basso DM, Knapp L. Comparison of two continuous passive motion protocols for patients with total knee implants. Phys Ther. 1987 Mar;67(3):360-3. doi: 10.1093/ptj/67.3.360.
- Background: PubMed 3602101Belitsky RB, Odam SJ, Hubley-Kozey C. Evaluation of the effectiveness of wet ice, dry ice, and cryogenic packs in reducing skin temperature. Phys Ther. 1987 Jul;67(7):1080-4. doi: 10.1093/ptj/67.7.1080.
- Background: PubMed 15062707Bonutti PM, Mont MA, Kester MA. Minimally invasive total knee arthroplasty: a 10-feature evolutionary approach. Orthop Clin North Am. 2004 Apr;35(2):217-26. doi: 10.1016/j.ocl.2004.02.001.
- Background: PubMed 17897861Chatap G, De Sousa A, Giraud K, Vincent JP; Acute Pain in the Elderly Study Group. Pain in the elderly: Prospective study of hyperbaric CO2 cryotherapy (neurocryostimulation). Joint Bone Spine. 2007 Dec;74(6):617-21. doi: 10.1016/j.jbspin.2006.10.011. Epub 2007 Jul 19.
- Background: PubMed 20229136Cheng T, Liu T, Zhang G, Peng X, Zhang X. Does minimally invasive surgery improve short-term recovery in total knee arthroplasty? Clin Orthop Relat Res. 2010 Jun;468(6):1635-48. doi: 10.1007/s11999-010-1285-9. Epub 2010 Mar 13.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Moreau, MSc principal investigator
Centre Hospitalier de Verdun
Questions about this trial
What is this clinical trial studying?
A study testing Cryoton ™ in people with Osteoarthritis, Knee, run by Centre Hospitalier de Verdun.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in active and passive knee flexion ROM measured by analysis. (time frame: Between post-operative day 1 and 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02516280, which also lists 58 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2015.