Patella AltaNCT05854056
Tibial Tubercle Distalisation and Accelerated Rehabilitation
A study testing Accelerated rehabilitation protocol and Conservative rehabilitation protocol in people with Patella Alta and Tibial Tubercle Distalisation Osteotomy, run by Tampere University Hospital.
Trial summary
The goal of this clinical trial is to compare in distalising tibial tubercle osteotomy procedure group fast rehabilitation to traditional rehabilitation. The main questions it aims to answer are: Will the novel accelerated rehabilitation protocol lead to faster recovery and improved functional outcome at 6, 12 and 24… Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Patella Alta, Tibial Tubercle Distalisation Osteotomy, Rehabilitation
- What is being tested?
- Accelerated rehabilitation protocol and Conservative rehabilitation protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Dec 2025
- 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 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Symptomatic patella alta with recurrent dislocation or subluxation. Long-lasting anterior knee pain not responding to rehabilitation.
Who cannot join
- Radiographic:
- Open growth plates
- Iwano [8] grade III and IV changes in patellofemoral joint
- Caton-Deschamps <1.1 in MRI
- PTI >50% in MRI
- High grade trochlear dysplasia
Show all 13Show fewer
- General:
- Refuses to participate in the study
- Aged less than 15 or more than 35 years
- Severe neurological, pulmonal or cardiovascular comorbidities that are contraindications for surgery
- Lack of adequate co-operation
- Does not adequately understand written and spoken instructions in the local language
- Those patients who decline to take part in the trial will be asked to join a follow-up cohort as a background population. The patients in this follow-up cohort will be treated "as normal" without allocation, but the follow-up questionnaires will be the same as those given to the randomly assigned population. The patients in the follow-up cohort will also be asked to provide informed written consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Accelerated Postoperative Rehabilitation After Tibial Tubercle Distalisation: a Randomised Controlled Trial Protocol
The goal of this clinical trial is to compare in distalising tibial tubercle osteotomy procedure group fast rehabilitation to traditional rehabilitation.
The main questions it aims to answer are:
Read more
- Will the novel accelerated rehabilitation protocol lead to faster recovery and improved functional outcome at 6, 12 and 24 weeks compared with the conservative rehabilitation protocol?
- Will the complication rate be similar in both groups?
Participants will be following fast rehabilitation or the traditional rehabilitation guidelines after distalising tibial tubercle osteotomy procedure according to the randomisation.
Researchers will compare fast rehabilitation group to the traditional rehabilitation group to see if recovery and functional outcome is improved in fast rehabilitation group and complication rate will be similar in both groups.
Read the detailed description
Patella alta is a clinical condition where the patella is positioned too proximal in relation to the femoral trochlea. Such an abnormality may cause patellar instability and predispose to recurrent patellofemoral dislocations and patellofemoral pain. There are no conclusive guidelines for determining a threshold for too high positioned patella, as several different methods have been described to measure patellar height. As a surgical solution, distalising tibial tubercle osteotomy has been described to correct excessive patellar height.
In the early phase of the distalising tibial tubercle osteotomy postoperative protocol, weightbearing and knee flexion are limited with a brace commonly for 4-8 weeks. The potential risks for adverse effects associated with the limitation rehabilitation protocol include a delay in regaining knee range of motion, stiffness and muscle weakness. As a result, recovery from surgery is delayed and may lead to additional procedures and long-term morbidity in knee function.
This is a prospective, randomised, controlled, single-blinded, single centre trial comparing a novel accelerated rehabilitation protocol with the traditional, motion restricting rehabilitation protocol. All skeletally mature patients aged 35 years and younger, referred to as the distalising tibial tubercle osteotomy procedure group, are eligible for inclusion in the study. Patients will be randomised to either the fast rehabilitation group or the traditional rehabilitation group. Patients with patellar instability will be additionally treated with medial patellofemoral ligament reconstruction.
The hypothesis of the trial is that the novel accelerated rehabilitation protocol will lead to faster recovery and improved functional outcome at 6, 12 and 24 weeks compared with the conservative rehabilitation protocol. A secondary hypothesis is that the complication rate will be similar in both groups.
The study will document short-term recovery and the planned follow-up will be 3 years. After the 1-year follow-up, the trial results will be disseminated in a major peer-reviewed orthopaedic publication.
- Being tested
- Accelerated rehabilitation protocol, Conservative rehabilitation protocol
- Keywords
- Patella Alta, Tibial tubercle distalisation osteotomy, Accelerated rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated rehabilitation protocolProcedure or surgery
See Arms section
Conservative rehabilitation protocolProcedure or surgery
See Arms section
| Study group | Role | What they receive |
|---|---|---|
| Accelerated rehabilitation protocol | Active comparator | Elements of physical therapy Group 1 Accelerated rehabilitation Antioedema knee, calf, leg Day 1 Knee brace, ROM limitations No Weight-bearing limitations No, crutches are recommended for 4 weeks. Active exercises. Functional exercises. 1 week Active dynamic strengthening exercises. 5 weeks Closed chain exercises for muscle strengthening. 8 weeks Muscle endurance and neuromuscular control, progress strengthening exercises, jogging 12 weeks Receives: Procedure: Accelerated rehabilitation protocol |
| Conservative rehabilitation protocol | Active comparator | Elements of physical therapy Group 2 Conservative rehabilitation Antioedema knee, calf, leg Day 1 Knee brace, ROM limitations 6 weeks Weight-bearing limitations 4 weeks limb weight, followed by half body weight till week 6
Active exercises. Functional exercises. 8 weeks Active dynamic strengthening exercises. 8 weeks Closed chain exercises for muscle strengthening. 8 weeks Muscle endurance and neuromuscular control, progress strengthening exercises, jogging 12 weeks Receives: Procedure: Conservative rehabilitation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome in this study will be knee range of motion (ROM) measured at 12 weeks postoperatively.
A difference of 10º in full range of movement will be considered significant. The results will be measured with a long goniometer in a standardised manner.
Measured: At 12 weeks
Secondary outcomes (1)
Secondary outcomes will be knee the Knee Injury and Osteoarthritis Outcome Score (KOOS).
KOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living, Function in sport and recreation and knee related Quality of life. The baseline score from KOOS is recorded during the physiotherapist visit.
Measured: measured at baseline, 6, 24 and 52 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Patella AltaStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pihlajalinna Hospital, Tampere
- Responsible party
- Sponsor
- Investigators
- Frederick Weitz, Study chair, PihlajalinnaVille M Mattila, Prof, Study chair, Department of Orthopaedic Surgery, Tampere University Hospital, Tampere, FinlandErkki Nilkku, Study chair, PihlajalinnaPetri J Sillanpää, Study chair, Pihlajalinna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854056
- Sponsor's protocol ID
- R22072
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The copyright of the trial research data will be owned and created by the participating research parties. The data will be shared among all participating researchers who will receive access to the data after the trial is completed. Due to confidentiality and legal agreements, public data sharing will be restricted because we only have permission to hold the data in the specific research server, not to transfer data. Under certain circumstances, for example, when a new member joins the collaboration, we will grant access to the data.
Publications
Biedert RM, Tscholl PM. Patella Alta: A Comprehensive Review of Current Knowledge. Am J Orthop (Belle Mead NJ). 2017 Nov/Dec;46(6):290-300.
PubMed 29309446Insall J, Salvati E. Patella position in the normal knee joint. Radiology. 1971 Oct;101(1):101-4. doi: 10.1148/101.1.101. No abstract available.
PubMed 5111961Caton J. [Method of measuring the height of the patella]. Acta Orthop Belg. 1989;55(3):385-6. French.
PubMed 2603679Caton J, Mironneau A, Walch G, Levigne C, Michel CR. [Idiopathic high patella in adolescents. Apropos of 61 surgical cases]. Rev Chir Orthop Reparatrice Appar Mot. 1990;76(4):253-60. French.
PubMed 2148403Sherman SL, Erickson BJ, Cvetanovich GL, Chalmers PN, Farr J 2nd, Bach BR Jr, Cole BJ. Tibial Tuberosity Osteotomy: Indications, Techniques, and Outcomes. Am J Sports Med. 2014 Aug;42(8):2006-17. doi: 10.1177/0363546513507423. Epub 2013 Nov 6.
PubMed 24197613Ambra LF, Phan A, Gomoll AH. A New Technique for Distalization of the Tibial Tubercle That Allows Preservation of the Proximal Buttress. Orthop J Sports Med. 2018 Sep 25;6(9):2325967118798621. doi: 10.1177/2325967118798621. eCollection 2018 Sep.
PubMed 30263901Mansourvar M, Ismail MA, Raj RG, Kareem SA, Aik S, Gunalan R, Antony CD. The applicability of Greulich and Pyle atlas to assess skeletal age for four ethnic groups. J Forensic Leg Med. 2014 Feb;22:26-9. doi: 10.1016/j.jflm.2013.11.011. Epub 2013 Dec 3.
PubMed 24485416Iwano T, Kurosawa H, Tokuyama H, Hoshikawa Y. Roentgenographic and clinical findings of patellofemoral osteoarthrosis. With special reference to its relationship to femorotibial osteoarthrosis and etiologic factors. Clin Orthop Relat Res. 1990 Mar;(252):190-7.
PubMed 2302884Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008 Nov 11;337:a2390. doi: 10.1136/bmj.a2390.
PubMed 19001484Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.
PubMed 2805470Rahnel T, Weitz FK, Mattila VM, Reito A, Nilkku E, Launonen AP, Sillanpaa PJ. Effect of accelerated postoperative rehabilitation after tibial tubercle distalisation: A randomised controlled trial protocol. PLoS One. 2024 Jul 11;19(7):e0304075. doi: 10.1371/journal.pone.0304075. eCollection 2024.
PubMed 38990868
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Accelerated Postoperative Rehabilitation After Tibial Tubercle Distalisation: a Randomised Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT05854056
- Acronym / sponsor ID
- R22072
- Keywords
- Patella Alta, Tibial tubercle distalisation osteotomy, Accelerated rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Pihlajalinna Hospital, Tampere
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 May 2023 (actual)
- 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.
The goal of this clinical trial is to compare in distalising tibial tubercle osteotomy procedure group fast rehabilitation to traditional rehabilitation.
The main questions it aims to answer are:
- Will the novel accelerated rehabilitation protocol lead to faster recovery and improved functional outcome at 6, 12 and 24 weeks compared with the conservative rehabilitation protocol?
- Will the complication rate be similar in both groups?
Participants will be following fast rehabilitation or the traditional rehabilitation guidelines after distalising tibial tubercle osteotomy procedure according to the randomisation.
Researchers will compare fast rehabilitation group to the traditional rehabilitation group to see if recovery and functional outcome is improved in fast rehabilitation group and complication rate will be similar in both groups.
Detailed description
Patella alta is a clinical condition where the patella is positioned too proximal in relation to the femoral trochlea. Such an abnormality may cause patellar instability and predispose to recurrent patellofemoral dislocations and patellofemoral pain. There are no conclusive guidelines for determining a threshold for too high positioned patella, as several different methods have been described to measure patellar height. As a surgical solution, distalising tibial tubercle osteotomy has been described to correct excessive patellar height.
In the early phase of the distalising tibial tubercle osteotomy postoperative protocol, weightbearing and knee flexion are limited with a brace commonly for 4-8 weeks. The potential risks for adverse effects associated with the limitation rehabilitation protocol include a delay in regaining knee range of motion, stiffness and muscle weakness. As a result, recovery from surgery is delayed and may lead to additional procedures and long-term morbidity in knee function.
This is a prospective, randomised, controlled, single-blinded, single centre trial comparing a novel accelerated rehabilitation protocol with the traditional, motion restricting rehabilitation protocol. All skeletally mature patients aged 35 years and younger, referred to as the distalising tibial tubercle osteotomy procedure group, are eligible for inclusion in the study. Patients will be randomised to either the fast rehabilitation group or the traditional rehabilitation group. Patients with patellar instability will be additionally treated with medial patellofemoral ligament reconstruction.
The hypothesis of the trial is that the novel accelerated rehabilitation protocol will lead to faster recovery and improved functional outcome at 6, 12 and 24 weeks compared with the conservative rehabilitation protocol. A secondary hypothesis is that the complication rate will be similar in both groups.
The study will document short-term recovery and the planned follow-up will be 3 years. After the 1-year follow-up, the trial results will be disseminated in a major peer-reviewed orthopaedic publication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerated rehabilitation protocol | Active comparator | Procedure: Accelerated rehabilitation protocolElements of physical therapy Group 1 Accelerated rehabilitation Antioedema knee, calf, leg Day 1 Knee brace, ROM limitations No Weight-bearing limitations No, crutches are recommended for 4 weeks. Active exercises. Functional exercises. 1 week Active dynamic strengthening exercises. 5 weeks Closed chain exercises for muscle strengthening. 8 weeks Muscle endurance and neuromuscular control, progress strengthening exercises, jogging 12 weeks |
| Conservative rehabilitation protocol | Active comparator | Procedure: Conservative rehabilitation protocolElements of physical therapy Group 2 Conservative rehabilitation Antioedema knee, calf, leg Day 1 Knee brace, ROM limitations 6 weeks Weight-bearing limitations 4 weeks limb weight, followed by half body weight till week 6 Active exercises. Functional exercises. 8 weeks Active dynamic strengthening exercises. 8 weeks Closed chain exercises for muscle strengthening. 8 weeks Muscle endurance and neuromuscular control, progress strengthening exercises, jogging 12 weeks |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Symptomatic patella alta with recurrent dislocation or subluxation. Long-lasting anterior knee pain not responding to rehabilitation.
Key exclusion criteria (13 listed)
- Open growth plates
- Iwano [8] grade III and IV changes in patellofemoral joint
- Caton-Deschamps <1.1 in MRI
- PTI >50% in MRI
- High grade trochlear dysplasia
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 |
|---|---|---|
| Accelerated rehabilitation protocolSee Arms section | Procedure or surgery | Accelerated rehabilitation protocol |
| Conservative rehabilitation protocolSee Arms section | Procedure or surgery | Conservative rehabilitation protocol |
Primary outcome
The primary outcome in this study will be knee range of motion (ROM) measured at 12 weeks postoperatively.
Time frame: At 12 weeks
A difference of 10º in full range of movement will be considered significant. The results will be measured with a long goniometer in a standardised manner.
1 secondary outcome
Secondary outcomes will be knee the Knee Injury and Osteoarthritis Outcome Score (KOOS).
Time frame: measured at baseline, 6, 24 and 52 weeks postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Background: PubMed 29309446Biedert RM, Tscholl PM. Patella Alta: A Comprehensive Review of Current Knowledge. Am J Orthop (Belle Mead NJ). 2017 Nov/Dec;46(6):290-300.
- Background: PubMed 5111961Insall J, Salvati E. Patella position in the normal knee joint. Radiology. 1971 Oct;101(1):101-4. doi: 10.1148/101.1.101. No abstract available.
- Background: PubMed 2603679Caton J. [Method of measuring the height of the patella]. Acta Orthop Belg. 1989;55(3):385-6. French.
- Background: PubMed 2148403Caton J, Mironneau A, Walch G, Levigne C, Michel CR. [Idiopathic high patella in adolescents. Apropos of 61 surgical cases]. Rev Chir Orthop Reparatrice Appar Mot. 1990;76(4):253-60. French.
- Background: PubMed 24197613Sherman SL, Erickson BJ, Cvetanovich GL, Chalmers PN, Farr J 2nd, Bach BR Jr, Cole BJ. Tibial Tuberosity Osteotomy: Indications, Techniques, and Outcomes. Am J Sports Med. 2014 Aug;42(8):2006-17. doi: 10.1177/0363546513507423. Epub 2013 Nov 6.
- Background: PubMed 30263901Ambra LF, Phan A, Gomoll AH. A New Technique for Distalization of the Tibial Tubercle That Allows Preservation of the Proximal Buttress. Orthop J Sports Med. 2018 Sep 25;6(9):2325967118798621. doi: 10.1177/2325967118798621. eCollection 2018 Sep.
- Background: PubMed 24485416Mansourvar M, Ismail MA, Raj RG, Kareem SA, Aik S, Gunalan R, Antony CD. The applicability of Greulich and Pyle atlas to assess skeletal age for four ethnic groups. J Forensic Leg Med. 2014 Feb;22:26-9. doi: 10.1016/j.jflm.2013.11.011. Epub 2013 Dec 3.
- Background: PubMed 2302884Iwano T, Kurosawa H, Tokuyama H, Hoshikawa Y. Roentgenographic and clinical findings of patellofemoral osteoarthrosis. With special reference to its relationship to femorotibial osteoarthrosis and etiologic factors. Clin Orthop Relat Res. 1990 Mar;(252):190-7.
- Background: PubMed 19001484Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008 Nov 11;337:a2390. doi: 10.1136/bmj.a2390.
- Background: PubMed 2805470Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.
- Derived from this study: PubMed 38990868Rahnel T, Weitz FK, Mattila VM, Reito A, Nilkku E, Launonen AP, Sillanpaa PJ. Effect of accelerated postoperative rehabilitation after tibial tubercle distalisation: A randomised controlled trial protocol. PLoS One. 2024 Jul 11;19(7):e0304075. doi: 10.1371/journal.pone.0304075. eCollection 2024.
- Individual participant dataSharing planned: No. The copyright of the trial research data will be owned and created by the participating research parties. The data will be shared among all participating researchers who will receive access to the data after the trial is completed. Due to confidentiality and legal agreements, public data sharing will be restricted because we only have permission to hold the data in the specific research server, not to transfer data. Under certain circumstances, for example, when a new member joins the collaboration, we will grant access to the data.
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.
Frederick Weitz study chair
Pihlajalinna
Ville M Mattila, Prof study chair
Department of Orthopaedic Surgery, Tampere University Hospital, Tampere, Finland
Erkki Nilkku study chair
Pihlajalinna
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated rehabilitation protocol and Conservative rehabilitation protocol in people with Patella Alta and Tibial Tubercle Distalisation Osteotomy, run by Tampere University Hospital.
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 1 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 11 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timo Rahnel (+3725233242, timorahnel@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome in this study will be knee range of motion (ROM) measured at 12 weeks postoperatively. (time frame: At 12 weeks). 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 NCT05854056, which also lists 11 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 11 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.