Knee arthroscopy and exercise versus exercise only in relieving pain and disability in patients with chronic patellofemoral pain syndrome (PFPS). A randomized controlled trial.

ISRCTN	ISRCTN41800323
DOI	https://doi.org/10.1186/ISRCTN41800323
Secondary identifying numbers	N/A

Submission date: 01/11/2005
Registration date: 10/01/2006
Last edited: 03/03/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Urho Kujala
Scientific

Department of Health Sciences
University of Jyväskylä
P.O. Box 35 (LL)
Jyväskylä
FIN-40014
Finland

Phone	+358 (0)50 586 2712
Email	urho.kujala@sport.jyu.fi

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	Diagnostic and operative arthroscopy in addition to conservative treatment is equally effective as conservative treatment alone for patello-femoral pain syndrome.
Ethics approval(s)	Ethics committee approval from the Ethics Committee of the Hospital Districts of Helsinki and Uusimaa, date 30/04/2001.
Health condition(s) or problem(s) studied	Chronic (> 6 months before inclusion) patellofemoral pain syndrome.
Intervention	The aim of this study is to compare the value of diagnostic + operative arthroscopy with home exercise program (arthroscopy group) versus home exercise program only (control group) on subjects with chronic PFPS (patello-femoral pain syndrome). The knee arthroscopy is done one week after the baseline clinical examination by one of the two experienced knee orthopaedists. All knee compartments are examined systematically and pathological findings are recorded. During arthroscopy the following procedures are performed if justified based on the arthroscopy finding and according to our pre-determined quidelines: meniscal resections, resection of inflamed/scarred medial plicae, abrasion of chondral lesions and shaving of excessive and inflamed synovium. Minor corrections of the patellofemoral articulation are performed, such as lateral capsular discision. These cases do remain in the study group. When necessary, also meniscal refixation, ligament reconstruction and extensive chondral reconstruction are carried out according to current clinical praxis (OATS), even though these patients are not able to participate in standardised training protocol according to the study time-table. The 8-weeks home exercise program starts 14 days after knee arthroscopy among arthroscopy group and three weeks after the randomization and baseline examination among both groups.
Intervention type	Other
Primary outcome measure	Kujala score, which is a 13-item questionnaire with discrete categories related to various levels of knee function. Categories within each item are weighted, and responses are summed to provide an overall index in which 100 represents no disability. Among other things, the questionnaire evaluates pain or disability related to the loading of the patellofemoral joint during sitting, walking, running, jumping, and stair climbing. (Kujala et al. Scoring of patellofemoral disorders. Arthroscopy 1993;9:159-63). Many authors who have used this score later have termed it as 'the Anterior Knee Pain Scale (AKPS)'. Main follow-up time-point is 37 weeks after randomization (= 6 months after the exercise training period started three weeks after randomization in both treatment groups). Other time-points when the main outcome is measured are before the randomization, 11 weeks after randomization (immediately after the 8 week home training period = 10 weeks after arthroscopy), 63 week follow-up (= 12 months after the training period), and 115 week follow-up (= 24 months after the training period).
Secondary outcome measures	Three different 10 cm visual analog scales (VASs) to assess activity related pains. Participants assess maximum pain in the previous two days during ascending stairs, descending stairs, and standing up, where 0 = no pain and 100 = extremely intense pain. Also, a global rating of change (overall assessment) is evaluated with an additional 6-point scale: 1 = asymptomatic knee to 6 = marked worsening than before treatment. The subjects also keep a diary related to possible adverse effects and use of drugs as well as on other treatments not related to the study protocol. Adverse effects and a cost-effectiveness analysis will be reported.
Overall study start date	12/02/2003
Completion date	02/02/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	56
Key inclusion criteria	In the first phase, orthopaedists select consecutive female or male patients who are admitted to the hospital policlinic of either ORTON Orthopaedic Hospital, Helsinki or one of the orthopaedic policlinics of the Hospital District of Helsinki and Uusimaa and who amongst them fulfil the following inclusion criteria: 1. Subjects that are 18 to 40 years of age female or male and have a characteristic history and symptoms of PFPS for at least six months 2. They have patellofemoral pain during physical activities, such as jumping, running, squatting, and going up or down stairs; patellofemoral pain when the knee is kept in flexion for a prolonged period, with relief on extension; and possibly, patellar snapping, pseudo-locking, giving-way, stiffness, or periodic effusions in conjunction with physical activity. Subjects with patellar subluxation but not with a history of patellar dislocation, are included.
Key exclusion criteria	1. Subjects with disabling general illnesses, report knee ligamentous or meniscal injuries, previous knee surgery, physician diagnosed knee osteoarthritis or a history of patellar dislocation 2. Subjects who have been in physical therapy for PFPS within the previous 4 weeks 3. Subjects who are pregnant 4. Subjects who are competitive athletes and therefore may have pain syndrome related to extreme loading and perhaps not be willing to follow the treatment protocols 5. Subjects with antero-posterior or medio-lateral instability in manual instability measurement or with knee problems other than PFPS (such as jumper's knee or knee meniscal injury) based on clinical evaluation 6. Subjects with knee osteoarthritis, osteochondritis dissecans, loose bodies in the patellofemoral and tibiofemoral joints, or with knee problems other than PFPS are excluded based on the findings in the knee x-ray examination
Date of first enrolment	12/02/2003
Date of final enrolment	02/02/2005

Locations

Countries of recruitment

Finland

Study participating centre

Department of Health Sciences

Jyväskylä
FIN-40014
Finland

Sponsor information

Social Insurance Institution of Finland
Government

Timo Klaukka
Chief of Health Research
Research Department
P.O. Box 450
Helsinki
FIN-00101
Finland

Phone	+358 (0)20 4343284
Email	timo.klaukka@kela.fi
"ROR"	https://ror.org/057yw0190

Funders

Funder type

Research organisation

Social Insurance Institution of Finland and ORTON Research Institute, Invalid Foundation.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	13/12/2007		Yes	No
Results article	results	01/03/2012		Yes	No