The objective of this study is to evaluate the effectiveness and cost-effectiveness of surgical and conservative treatment of non-obstructive meniscal injuries in older patientsHypothesis: We assume equal improvement of physical function in both…
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Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome will be change in physical function from baseline to 2 years
measured by the International Knee Documentation Committee (IKDC) 'Subjective
Knee Form', which has been validated for meniscal injuries (18).
In addition, we will perform an economic analysis alongside the RCT from a
societal perspective and a budget impact analysis from societal, government and
insurer perspective.
Secondary outcome
SECONDARY OUTCOMES:
1) Change in:
- General health, measured by RAND-36;
- Quality of life, measured by EQ-5D5L;
- Pain, measured by the VAS for pain, both in rest and at weight bearing;
- Level of activity, measured by Tegner Activity Scale (TAS);
- Patient specific complaints measured by the PSC (patient specific complaints)
Questionnaire;
- Treatment group; number of patients initially treated conservatively, treated
secondarily by APM.
We will use the EQ-5D5L to measure Quality Adjusted Life Years (QALY).
2) Productivity losses, measured by Trimbos/iMTA questionnaire for Costs
associated with Psychiatric Illness (TiC-P).
3) Participants expectation of treatment and their satisfaction.
4) Physical Examination (PE), consisting of performance on physical tests
(squatting with duckwalk, Thessely test, McMurray), the range of motion, joint
line tenderness and the existence of hydrops in the knee.
5) Adverse events including:
-Minor: prolonged synovial fluid leakage from arthroscopy portals and bleeding
-Moderate: surgical site infection, vascular and neurological damage
-Severe: septic arthritis, cardiac events, pulmonary embolism and death
Surgical instrument malfunction will be recorded, as well as reoperations
including knee arthroplasties and re-hospitalization.
Background summary
Current standard treatment of symptomatic non-obstructive meniscal tears in
older patients is surgery. Annual costs are 33 million Euros in this patient
group (N=15.000) in the Netherlands. Nevertheless, evidence is lacking that
supports its superiority over conservative treatment. When conservative
treatment is non-inferior to surgery, this strategy alone could save over 12
million Euros on an annual basis.
We therefore risk large healthcare inefficiency, since these patients are
treated surgically. The financial benefits of conservative treatment might even
be enhanced by an anticipated decrease in the progression to knee
osteoarthritis, since fewer knee arthroplasties would be necessary. This could
even further decrease the annual costs spent on knee surgeries.
Study objective
The objective of this study is to evaluate the effectiveness and
cost-effectiveness of surgical and conservative treatment of non-obstructive
meniscal injuries in older patients
Hypothesis:
We assume equal improvement of physical function in both groups and reduced
costs with conservative treatment.
Study design
A non-inferiority multicenter randomized controlled trial (RCT) with an
economic evaluation alongside. The study will be conducted by the Orthopaedic
Research Consortium Mid-West Netherlands and performed in 8 clinics, including
2 academic medical centers.
Intervention
Intervention group:
Arthroscopic partial APM is performed within 4 weeks in day-care by an
orthopaedic surgeon experienced in arthroscopic surgery, or by a resident
skilled in athroscopic knee surgery under direct supervision of an orthopaedic
surgeon experienced in arthroscopic surgery. Eight weeks after surgery (3
months after randomization), patients will visit the outpatient department to
check for function and persistence of symptoms. Since standard Physical therapy
(PT) after APM has not been proven effective, patients will only be referred to
a physical therapist in case of swelling or signs of atrophy, as advised by the
Dutch Orthopaedic Association Guidelines (1).
Control group:
PT consists of 2 sessions of 30 minutes per week for 8 weeks, with a total of
16 sessions. Patients will also be given a home exercise program (appendix B).
These programs are based on a physical therapy program used by Herrlin et al.
(6) and is adjusted for our population by a physical therapist (dr. C. Neeter;
member of the research group) who earned his PhD degree in the field of the
anterior cruciate ligament and is specialized on the knee.
After completion of the PT-sessions, patients will visit the outpatient
department to check for function and persistence of symptoms.
Delayed surgery group:
In case symptoms persist or get worse, patients can undergo delayed APM after
at least 8 weeks. We expect this to occur only in the first few months, when it
appears that PT has failed. Prior to the APM patients will be asked to answer
an extra questionnaire as endpoint of PT. Patients in this group will be
analysed in the PT group according to the Intention-to-treat principle.
Study burden and risks
At baseline, when a meniscal tear is suspected at presentation, an MRI-scan
will be obtained. This is not seen as an extra burden for participants, since
an MRI which has a high sensitivity and specificity normally is usually made to
avoid unnecessary diagnostic arthroscopies as stated in the guideline for
arthroscopy of the knee, 2010 (NOV) (1).
All patients approached and willing to participate in the trial will be
randomized when all inclusion criteria are met when they return to the
outpatient department for the results of the MRI.
Participants will be randomized into the surgical group or the conservative
group and are followed at 3, 6, 9, 12, 18 and 24 months.
The risks associated with participation in the trial include the general risks
for surgery, e.g. infection, bleeding, postoperative numbness, paralysis, pain,
persistence of symptoms when randomized into the surgical group. In the
conservative group, no specific risks are known to occur. Since surgery is
current standard treatment, there are no additional risks for participation in
this trial.
All patients will return to the outpatient department after 3 and 24 months.
This will be for PE (3 and 24 months) and X-rays (24 months).
We plan a follow up moment at 60 months to see the progression of
osteoarthritis, measured with the Kellgren Lawrence Grading Scale for
Osteoarthritis.
The burden of the extra X-ray will be negligible, especially when focussed on
the potential outcome of the trial, which could lead to a significant reduction
of unnecessary surgeries.
All questionnaires will be obtained digitally and can be completed at home. If
preferred, a hardcopy can be sent to these participants.
Completion of the questionnaires will take approximately 30 minutes. The
questionnaires at 9 and 18 months, consisting only of EQ-5D-5L and TiC-P for
economical analyses, will take only 5 minutes to complete.
Oosterpark 9
Amsterdam 1091 AC
NL
Oosterpark 9
Amsterdam 1091 AC
NL
Listed location countries
Age
Inclusion criteria
1) Patients between 45 and 70 years of age at presentation.
2) A meniscal tear visualized on MRI. The meniscal tear can either be isolated or combined with a partial asymptomatic anterior cruciate ligament (ACL) injury or a asymptomatic degenerative ACL shown on MRI with no abnormal clinical findings (a negative Lachman test and Pivot Shift).
3) Mental Competence.
4) Willingness to comply with follow-up schedule.
5) Written informed consent.
Exclusion criteria
1) Knee locking or trauma leading to acute surgery.
2) One of the following associated injuries on the index knee:
a. A symptomatic partial ACL rupture or any total ACL rupture determined by clinical examination (positive Lachman test and/or positive Pivot Shift) and shown on MRI;
b. A complete PCL injury;
c. Cartilage change down to bone; grade 4 of the Kellgren Lawrence Grading Scale for Osteoarthritis visualized on X-ray;
d. An injury to the lateral/posterolateral ligament complex with significantly increased laxity.
3) A history of knee surgery other than diagnostic arthroscopy on the index knee.
4) Tumors on MRI suspected for a malignancy.
5) Obese patients with BMI > 35.
6) ASA 4-5 (appendix D) patients with can interfere with revalidation.
7) General disease that effects physical function or systemic medication/abuse of steroids (e.g., rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout, pseudogout)
8) Any other medical condition or treatment interfering with the completion or assessment of the trial, e.g. contraindications to MRI or surgery.
9) Drugs or alcohol abuse.
10) Patients unable to speak or read Dutch.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Clinicaltrials.gov: NCT01850719 / NTR: TC = 3908 |
| CCMO | NL44188.100.13 |