Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement

Osteoarthritis of the Knee Clinical Trial

— MEDIC  

Official title:

Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement. A Randomized Controlled Trial of Pain, Physical Function and Quality of Life With 12months Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410409
• Other study ID #: N-20110024
• Status: Completed
• Phase: N/A
• First received: August 2, 2011
• Last updated: September 14, 2017
• Start date: September 2011
• Est. completion date: March 2015

Study information

• Verified date: September 2017
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test whether surgical insertion of total knee replacement provides further improvement in quality of life, pain and function in addition to an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, NSAIDs and Pantoprazol in patients with knee OA, collectively called the MEDIC-treatment(Medicine Exercise Diet Insoles Cognitive).

The H1-hypothesis is that surgery with insertion of TKR in addition to the MEDIC-treatment results in a greater increase in quality of life and functional capacity and greater reduction in pain than the MEDIC- treatment alone at the primary endpoint, which is follow-up 12months after the start of the treatment.

See statistical analysis plan available under "Links" for further description of the study.

Description:

Knee osteoarthritis (OA) is the degenerative joint disease that most often requires treatment and at the same time the one associated with the greatest social costs. In addition, the disease has many personal costs and is greatly contributing to reduced functionality and autonomy of older adults.

It is recommended both nationally and internationally that the treatment of knee OA should include multiple treatment modalities. Clinical guidelines recommend that exercise, weight loss and patient education is the first step in treatment and that insoles and pharmacological treatment can be included as a supplement. If this non-surgical treatment is ineffective surgical treatment, especially surgery with insertion of total knee replacement (TKR), may be indicated. There are effects of both non-surgical treatment and TKR, but no studies exist, which examine the effect of surgery with insertion of TKR in addition to the recommended non-surgical treatment of knee OA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Knee-OA detected by x-ray (Kellgren & Lawrence grade 2 or greater)

• Considered a candidate for TKR by the orthopedic surgeon.

• The participant is > 18 years of age.

• The participant can provide relevant and adequate, informed consent.

Exclusion Criteria:

• Bilateral simultaneous TKR

• Revision of prior TKR, unicompartmental knee arthroplasty or high tibial osteotomy

• Rheumatoid arthritis

• Mean VAS > 60mm on a 0-100mm scale

• Investigator considers that the mental condition of the participant does not allow participation.

• The participant must not be pregnant or plan pregnancy during the study.

• Inability to comply with the protocol;.

• Inadequacy in written and spoken Danish.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Other:
• Neuromuscular training (NEMEX-TJR)
60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.

Drug:
• Paracetamol
1 g x 4/day
• Burana
400 mg x 3/day for three weeks
• Pantoprazol
20mg x 1/day for three weeks

Behavioral:
• Dietary counseling
For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet and plans the number of visits according to the individual participant needs.
• Patient education
The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA. This aspect of the intervention is based on principles from The Chronic Disease Self-Management Program, "Lær at leve med kronisk sygdom (Learn to live with chronic illness)" by The National Board of Health, Denmark and "Artrosskolan Spenshult" in Sweden.

Procedure:
• TKR
Surgical treatment with insertion of total knee replacement following standard procedures.

Other:
• Insoles
The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral). The participants will be advised to use the insoles in all shoes.

Locations

Country	Name	City	State
Denmark	Department of Occupational and Physiotherapy, Aalborg University Hospital	Aalborg
Denmark	Farsoe Hospital	Farsø
Denmark	Vendsyssel Hospital, Frederikshavn	Frederikshavn

Sponsors (10)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark	Aalborg University, Association of Danish Physiotherapists, Danish Medical Association, Formthotics, Medical Specialist Heinrich Kopp's Grant, Obel Family Foundation, Spar Nord Foundation, The Bevica Foundation, The Danish Rheumatism Association

Country where clinical trial is conducted

Denmark, 

References & Publications (8)

Hunter DJ, Felson DT. Osteoarthritis. BMJ. 2006 Mar 18;332(7542):639-42. Review. — View Citation

Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M; Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1145-55. Review. — View Citation

National Board of Health, Denmark. Referenceprogram for knæartrose. Copenhagen: National Board of Health, Denmark; 2007. [22.02.2010] found at: http://www.sst.dk/publ/Publ2007/PLAN/SfR/Refprg_knaeartrose.pdf

Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis. 2001 Feb;60(2):91-7. Review. — View Citation

Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Rasmussen S. A Randomized, Controlled Trial of Total Knee Replacement. N Engl J Med. 2015 Oct 22;373(17):1597-606. doi: 10.1056/NEJMoa1505467. — View Citation

Walker-Bone K, Javaid K, Arden N, Cooper C. Regular review: medical management of osteoarthritis. BMJ. 2000 Oct 14;321(7266):936-40. Review. — View Citation

Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthritis Cartilage. 2007 Sep;15(9):981-1000. Epub 2007 Aug 27. Review. — View Citation

Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Outcomes	Pain intensities on a 100 mm VAS with terminal descriptors of 'no pain' and 'worst pain possible' in various situations.; Number of sites with pain in the previous 24 hours shaded on a region-divided body chart; Pain location and type assessed using the Knee Pain Map.; Maximum isometric muscle strength (converted to Nm using the length of the lower leg) measured bilaterally in knee flexion and knee extension in a make test using a handheld dynamometer (Powertrack II TM Commander from JTech Medical Industries, Salt Lake City, Utah, USA); Pressure pain thresholds measured bilaterally using a handheld algometer (Algometer Type II, Somedic AB, Hoerby, Sweden)) at five sites at the knee and the m. tibialis anterior muscle.; Self-efficacy in improving pain, function and QOL in various situations using a 100 mm VAS with terminal descriptors of 'very unsure' and 'very sure'.; Further exploratory objectives may be added later on.	Baseline, 3months, 6months, 12months and 24 months.
Primary	Change in KOOS4 From Baseline (Knee Injury and Osteoarthritis Outcome Score)	The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best). Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority.	Primary: 12months.
Secondary	Change in EQ-5D From Baseline	Between groups comparisons of the change from baseline to the 1 year follow-up in all secondary endpoint will be handled similar to the primary endpoint. See Statistical analysis plan for further description ("Links"); Range of EQ-5D Descriptive Index is -0.59 to 1.00 (worst to best), while the EQ VAS goes from 0 to 100 (worst to best).	Primary: 12months.
Secondary	Change in Timed Up & Go (TUG) From Baseline		Primary: 12months.
Secondary	Change in 20-meter Walk From Baseline		Primary: 12months.
Secondary	Change in the Five Subscales of KOOS From Baseline	All subscales going from 0 to 100 (worst to best)	Primary: 12months.
Secondary	Weight Change in kg From Baseline	Weight change in kg measured without shoes at the same time of day and on the same scale	Primary: 12months.
Secondary	Proportion of Users of Pain Medication	With possible answers being yes and no	Baseline and 12months.
Secondary	Serious Adverse Events Related to the Index Knee	Adverse events (AE) and seriously adverse events (SAE) will be registered in three ways and divided into index knee or sites other than index knee. The project physiotherapist will record any adverse events that the participant experiences or tells them about. For the participants allocated to, or crossing over to, TKA, a project worker will look through hospital records to register if any pre-defined perioperative and postoperative adverse events occurred. At all follow-ups, the assessor will use open-probe questioning to assess adverse events in all participants	Primary: 12months

External Links

•   Link to the published statistical analysis plan